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Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Irbesartan
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV Left ventricular ejection fraction (LVEF) > = 45% Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease. Exclusion Criteria: Acute myocardial infarction within 3 months; Heart revascularization procedure within 3 months; Hospitalization for angina within 3 months; Other heart surgery Life-threatening or uncontrolled arrhythmia Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months; Stroke or surgery of the arteries in the brain within 3 months; Serious lung disease which requires use of home oxygen. Significantly low blood pressure Significantly high blood pressure Other known diseases that may limit life expectancy to <3 years; Known or suspected bilateral kidney artery narrowing; Geographic or social factors making study participation and follow-up impractical.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.

Secondary Outcome Measures

Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
Treatment comparisons for time to heart failure mortality or heart failure hospitalization
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.
Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
Treatment comparisons for time to cardiovascular death
Percentage of Participants Experiencing All-cause Death at Given Time Points
Treatment comparisons for time to all-cause death
Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.
Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.
Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.

Full Information

First Posted
November 1, 2004
Last Updated
March 18, 2015
Sponsor
Bristol-Myers Squibb
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00095238
Brief Title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Official Title
Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Sanofi

4. Oversight

5. Study Description

Brief Summary
The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Intervention Description
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, titration from 75 to 300 mg, once daily up to 6 years
Primary Outcome Measure Information:
Title
Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
Description
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary Outcome Measure Information:
Title
Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
Description
Treatment comparisons for time to heart failure mortality or heart failure hospitalization
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Title
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
Description
Mean score and adjusted mean change from baseline in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Time Frame
Baseline, Month 6, Month 14
Title
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
Description
Mean score at baseline and final visit in Minnesota Living with Heart Failure (MLWHF) questionnaire, a 21-item, patient-reported, 6-point (ranging from 0-5; higher score=poorer quality of life; highest possible score=105) measurement of quality of life in persons with heart failure.
Time Frame
Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Title
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
Description
Adjusted ratio to baseline in geometric mean in Pro-BNP in the blood. Ratio to Baseline = On-therapy geometric mean divided by baseline geometric mean. A lower score signifies improvement. Change from baseline adjusted for baseline value and angiotensin converting enzyme inhibitor use at baseline. Analysis uses natural logarithms of excretion rate values.
Time Frame
Baseline, Month 6, Month 14
Title
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
Description
Treatment comparisons for time to cardiovascular death, non-fatal MI, or non-fatal stroke.
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Title
Percentage of Participants Experiencing Cardiovascular Death at Given Timepoints
Description
Treatment comparisons for time to cardiovascular death
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Title
Percentage of Participants Experiencing All-cause Death at Given Time Points
Description
Treatment comparisons for time to all-cause death
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Title
Change From Baseline in the New York Heart Association (NYHA) Functional Class at Month 6, Month 10, Month 14, and Final Visit
Description
NYHA functional classification=4-tiered system relating symptoms to everyday activities & quality of life. (See Reporting Groups for description of each class.) Change of NYHA functional class from baseline was grouped into 3 categories: improved, unchanged, or worsened (based on case report form [CRF] assessment). If a post-randomization CRF assessment was missing or participant died, was hospitalized for worsening heart failure or discontinued study medication for worsening heart failure, the participant was classified as Major Event.
Time Frame
Baseline, Month 6, Month 10, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Title
Physician Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Description
This was an assessment of the change in overall physician opinion of change from baseline status. Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Time Frame
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Title
Participant Assessment of Heart Failure Status at Month 6, Month 14, and Final Visit Compared With Baseline
Description
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Time Frame
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Title
Participant Assessment of Fatigue at Month 6, Month 14, and Final Visit Compared With Baseline
Description
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Time Frame
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Title
Participant Assessment of Dyspnea at Month 6, Month 14, and Final Visit Compared With Baseline
Description
Assessments are directly based on the Case Report Form (CRF). If the post-randomization CRF assessment was missing and the subject died, was hospitalized for worsening heart failure, or discontinued study medication for worsening heart failure, the subject was considered as having a Major Event. Participants who are summarized under Major Events are categorized as Worsened Markedly.
Time Frame
Baseline, Month 6, Month 14, Final Visit. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Title
Percentage of Participants Experiencing CV Death or CV Hospitalization at Given Timepoints
Description
Treatment comparisons for time to CV death or CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Title
Percentage of Participants Experiencing Protocol-specified Cardiovascular (CV) Hospitalization at Given Timepoints
Description
Treatment comparisons for time to protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include hospitalizations ≥24 hrs or involve a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular dysrhythmia, atrial dysrhythmia or stroke that also requires intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. Protocol specified CV hospitalizations also include myocardial infarction or stroke occurring during any hospitalization.
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Title
Percentage of Participants With New Onset of Diabetes Among Subjects With No Prior Diabetes History at Given Timepoints
Description
Treatment comparisons for time to new onset of diabetes (from adverse event reporting) among subjects with no prior history of diabetes.
Time Frame
Year 1, Year 2, Year 3, Year 4, Year 5
Title
Mean Change From Baseline in Glomerular Filtration Rate (GFR) at Month 6, Month 18, and Month 30
Description
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Time Frame
Baseline, Month 6, Month 18, Month 30
Title
Mean Change From Baseline in Glomerular Filtration Rate (GFR)at Month 42, Month 54, Month 66
Description
Based on the Cockcroft-Gault formula calculation, a commonly used surrogate marker to estimate creatinine clearance, which in turn is an approximate measure of GFR. It employs serum creatinine measurements and a patient's weight to predict the creatinine clearance. Adjusted for baseline GFR and angiotensin-converting enzyme inhibitor use at baseline (ACE-I). A decrease from baseline signifies worsening. The adjusted mean change from baseline value is from the model (calculated prior to rounding), whereas the other two points are the baseline mean and post mean.
Time Frame
Baseline, Month 42, Month 54, Month 66
Title
Number of Participants With New Onset Atrial Fibrillation (AF) Among Those With No Prior AF History or Evidence of AF on Baseline Electrocardiograph (ECG)
Description
Frequency of new onset AF in participants with no prior AF history or evidence of AF on baseline ECG. Stratified by use of angiotensin-converting enzyme (ACE) inhibitors and measured by adverse events reporting and final ECG recording read by the investigator.
Time Frame
Baseline, Final Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female age >= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV Left ventricular ejection fraction (LVEF) > = 45% Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease. Exclusion Criteria: Acute myocardial infarction within 3 months; Heart revascularization procedure within 3 months; Hospitalization for angina within 3 months; Other heart surgery Life-threatening or uncontrolled arrhythmia Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months; Stroke or surgery of the arteries in the brain within 3 months; Serious lung disease which requires use of home oxygen. Significantly low blood pressure Significantly high blood pressure Other known diseases that may limit life expectancy to <3 years; Known or suspected bilateral kidney artery narrowing; Geographic or social factors making study participation and follow-up impractical.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Local Institution
City
Peoria
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Local Institution
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
Local Institution
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Diego
State/Province
California
Country
United States
Facility Name
Local Institution
City
San Francisco
State/Province
California
Country
United States
Facility Name
Local Institution
City
Farmington
State/Province
Connecticut
Country
United States
Facility Name
Local Institution
City
Jacksonville Beach
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Lake Worth
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Vero Beach
State/Province
Florida
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Peoria
State/Province
Illinois
Country
United States
Facility Name
Local Institution
City
Jeffersonville
State/Province
Indiana
Country
United States
Facility Name
Local Institution
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Local Institution
City
Chalmette
State/Province
Louisiana
Country
United States
Facility Name
Local Institution
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
Local Institution
City
Auburn
State/Province
Maine
Country
United States
Facility Name
Local Institution
City
Takoma Park
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Towson
State/Province
Maryland
Country
United States
Facility Name
Local Institution
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Haverhill
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Natick
State/Province
Massachusetts
Country
United States
Facility Name
Local Institution
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
Local Institution
City
Petoskey
State/Province
Michigan
Country
United States
Facility Name
Local Institution
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Local Institution
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
Local Institution
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Local Institution
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Local Institution
City
Lebanon
State/Province
New Hampshire
Country
United States
Facility Name
Local Institution
City
Elmer
State/Province
New Jersey
Country
United States
Facility Name
Local Institution
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Local Institution
City
Albany
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Bronx
State/Province
New York
Country
United States
Facility Name
Local Institution
City
East Syracuse
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Flushing
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Rochester
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Troy
State/Province
New York
Country
United States
Facility Name
Local Institution
City
Chapel Hill
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Concord
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
Local Institution
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Lorain
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Sandusky
State/Province
Ohio
Country
United States
Facility Name
Local Institution
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Local Institution
City
Flourtown
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Lancaster
State/Province
Pennsylvania
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Local Institution
City
Germantown
State/Province
Tennessee
Country
United States
Facility Name
Local Institution
City
Austin
State/Province
Texas
Country
United States
Facility Name
Local Institution
City
Lynchberg
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
South Boston
State/Province
Virginia
Country
United States
Facility Name
Local Institution
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Local Institution
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
Local Institution
City
San Martin
State/Province
Buenos Aires
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa Fe
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
Country
Argentina
Facility Name
Local Institution
City
Cordoba
Country
Argentina
Facility Name
Local Institution
City
Corrientes
Country
Argentina
Facility Name
Local Institution
City
Mendoza
Country
Argentina
Facility Name
Local Institution
City
Coffs Harbour
State/Province
New South Wales
Country
Australia
Facility Name
Local Institution
City
Concord
State/Province
New South Wales
Country
Australia
Facility Name
Local Institution
City
Garran
State/Province
New South Wales
Country
Australia
Facility Name
Local Institution
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
Local Institution
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Local Institution
City
Auchenflower
State/Province
Queensland
Country
Australia
Facility Name
Local Institution
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Local Institution
City
Woolloongabba
State/Province
Queensland
Country
Australia
Facility Name
Local Institution
City
Launceston
State/Province
Tasmania
Country
Australia
Facility Name
Local Institution
City
Geelong
State/Province
Victoria
Country
Australia
Facility Name
Local Institution
City
Prahran
State/Province
Victoria
Country
Australia
Facility Name
Local Institution
City
Aalst
Country
Belgium
Facility Name
Local Institution
City
AYE
Country
Belgium
Facility Name
Local Institution
City
Borgerhout
Country
Belgium
Facility Name
Local Institution
City
Genk-waterschei
Country
Belgium
Facility Name
Local Institution
City
Gent
Country
Belgium
Facility Name
Local Institution
City
Hasselt
Country
Belgium
Facility Name
Local Institution
City
HUY
Country
Belgium
Facility Name
Local Institution
City
Leuven
Country
Belgium
Facility Name
Local Institution
City
Verviers
Country
Belgium
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
Country
Brazil
Facility Name
Local Institution
City
Goiania-go
State/Province
Goias
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Facility Name
Local Institution
City
Campinas
State/Province
Sao Paulo
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo, Sp
State/Province
Sao Paulo
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
Country
Brazil
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Local Institution
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Local Institution
City
Ajax
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Rexdale
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Scarborough
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Weston
State/Province
Ontario
Country
Canada
Facility Name
Local Institution
City
Longueuil
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
St-Lambert
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Ste-Foy
State/Province
Quebec
Country
Canada
Facility Name
Local Institution
City
Prague 2
Country
Czech Republic
Facility Name
Local Institution
City
Prague 4
Country
Czech Republic
Facility Name
Local Institution
City
Prague 9
Country
Czech Republic
Facility Name
Local Institution
City
Usti Nad Labem
Country
Czech Republic
Facility Name
Local Institution
City
Copenhagen Nv
Country
Denmark
Facility Name
Local Institution
City
Copenhagen
Country
Denmark
Facility Name
Local Institution
City
Abbeville
Country
France
Facility Name
Local Institution
City
Cholet
Country
France
Facility Name
Local Institution
City
DAX
Country
France
Facility Name
Local Institution
City
GAP
Country
France
Facility Name
Local Institution
City
Langres
Country
France
Facility Name
Local Institution
City
Lille
Country
France
Facility Name
Local Institution
City
Montbeliard
Country
France
Facility Name
Local Institution
City
Paris Cedex 13
Country
France
Facility Name
Local Institution
City
Poissy
Country
France
Facility Name
Local Institution
City
Pontoise
Country
France
Facility Name
Local Institution
City
Provins
Country
France
Facility Name
Local Institution
City
Roubaix
Country
France
Facility Name
Local Institution
City
Rouen
Country
France
Facility Name
Local Institution
City
Saint Malo
Country
France
Facility Name
Local Institution
City
Tours
Country
France
Facility Name
Local Institution
City
Vandoeuvre Les Nancy
Country
France
Facility Name
Local Institution
City
Vichy Cedex
Country
France
Facility Name
Local Institution
City
Bad Homburg
Country
Germany
Facility Name
Local Institution
City
Berlin
Country
Germany
Facility Name
Local Institution
City
Goettingen
Country
Germany
Facility Name
Local Institution
City
Gunzenhausen
Country
Germany
Facility Name
Local Institution
City
Halle
Country
Germany
Facility Name
Local Institution
City
Homburg / Saar
Country
Germany
Facility Name
Local Institution
City
Jena
Country
Germany
Facility Name
Local Institution
City
Langen
Country
Germany
Facility Name
Local Institution
City
Leipzig
Country
Germany
Facility Name
Local Institution
City
Mainz
Country
Germany
Facility Name
Local Institution
City
Marburg
Country
Germany
Facility Name
Local Institution
City
Muenchen
Country
Germany
Facility Name
Local Institution
City
Regensburg
Country
Germany
Facility Name
Local Institution
City
Stuttgart
Country
Germany
Facility Name
Local Institution
City
Witten
Country
Germany
Facility Name
Local Institution
City
Wuerzburg
Country
Germany
Facility Name
Local Institution
City
Athens
Country
Greece
Facility Name
Local Institution
City
Patras
Country
Greece
Facility Name
Local Institution
City
Budapest
Country
Hungary
Facility Name
Local Institution
City
Debrecen
Country
Hungary
Facility Name
Local Institution
City
Siofok
Country
Hungary
Facility Name
Local Institution
City
Szeged
Country
Hungary
Facility Name
Local Institution
City
County Dublin
State/Province
Dublin
Country
Ireland
Facility Name
Local Institution
City
Dublin
Country
Ireland
Facility Name
Local Institution
City
Ascoli Piceno
Country
Italy
Facility Name
Local Institution
City
Bologna
Country
Italy
Facility Name
Local Institution
City
Brescia
Country
Italy
Facility Name
Local Institution
City
Cosenza
Country
Italy
Facility Name
Local Institution
City
Pavia
Country
Italy
Facility Name
Local Institution
City
Perugia
Country
Italy
Facility Name
Local Institution
City
Piacenza
Country
Italy
Facility Name
Local Institution
City
Roma
Country
Italy
Facility Name
Local Institution
City
Siena
Country
Italy
Facility Name
Local Institution
City
Trieste
Country
Italy
Facility Name
Local Institution
City
Udine
Country
Italy
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Local Institution
City
San Pedro Garza Garcia
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Local Institution
City
Aguascalientes
Country
Mexico
Facility Name
Local Institution
City
Alkmaar
Country
Netherlands
Facility Name
Local Institution
City
Almere
Country
Netherlands
Facility Name
Local Institution
City
Amersfoort
Country
Netherlands
Facility Name
Local Institution
City
Apeldoorn
Country
Netherlands
Facility Name
Local Institution
City
Assen
Country
Netherlands
Facility Name
Local Institution
City
Breda
Country
Netherlands
Facility Name
Local Institution
City
Delft
Country
Netherlands
Facility Name
Local Institution
City
Emmen
Country
Netherlands
Facility Name
Local Institution
City
Gorinchem
Country
Netherlands
Facility Name
Local Institution
City
Groningen
Country
Netherlands
Facility Name
Local Institution
City
Heemstede
Country
Netherlands
Facility Name
Local Institution
City
Helmond
Country
Netherlands
Facility Name
Local Institution
City
Hengelo Ov
Country
Netherlands
Facility Name
Local Institution
City
Nijmegen
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
Country
Netherlands
Facility Name
Local Institution
City
Sittard
Country
Netherlands
Facility Name
Local Institution
City
Sneek
Country
Netherlands
Facility Name
Local Institution
City
Veldhoven
Country
Netherlands
Facility Name
Local Institution
City
Vlaardingen
Country
Netherlands
Facility Name
Local Institution
City
Zaandam
Country
Netherlands
Facility Name
Local Institution
City
Baerum Postterminal
Country
Norway
Facility Name
Local Institution
City
Stavanger
Country
Norway
Facility Name
Local Institution
City
Tonsberg
Country
Norway
Facility Name
Local Institution
City
Bydgoszcz
Country
Poland
Facility Name
Local Institution
City
Katowice
Country
Poland
Facility Name
Local Institution
City
Piotrkow Tryb.
Country
Poland
Facility Name
Local Institution
City
Stalowa Wola
Country
Poland
Facility Name
Local Institution
City
Warszawa
Country
Poland
Facility Name
Local Institution
City
Wroclaw
Country
Poland
Facility Name
Local Institution
City
Lisbon
Country
Portugal
Facility Name
Local Institution
City
Matosinhos
Country
Portugal
Facility Name
Local Institution
City
Moscow
Country
Russian Federation
Facility Name
Local Institution
City
Saratov
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
Country
Russian Federation
Facility Name
Local Institution
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Morningside
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Parktown West
State/Province
Gauteng
Country
South Africa
Facility Name
Local Institution
City
Berea
State/Province
Kwa Zulu Natal
Country
South Africa
Facility Name
Local Institution
City
Congella
State/Province
Kwa Zulu Natal
Country
South Africa
Facility Name
Local Institution
City
A Coruna
Country
Spain
Facility Name
Local Institution
City
Barcelona
Country
Spain
Facility Name
Local Institution
City
Cordoba
Country
Spain
Facility Name
Local Institution
City
Madrid
Country
Spain
Facility Name
Local Institution
City
Malaga
Country
Spain
Facility Name
Local Institution
City
Murcia
Country
Spain
Facility Name
Local Institution
City
Palma de Mallorca
Country
Spain
Facility Name
Local Institution
City
Sevilla
Country
Spain
Facility Name
Local Institution
City
Valencia
Country
Spain
Facility Name
Local Institution
City
Zaragoza
Country
Spain
Facility Name
Local Institution
City
Falun
Country
Sweden
Facility Name
Local Institution
City
Gothenburg
Country
Sweden
Facility Name
Local Institution
City
Linkoping
Country
Sweden
Facility Name
Local Institution
City
Malmo
Country
Sweden
Facility Name
Local Institution
City
Skelleftea
Country
Sweden
Facility Name
Local Institution
City
Stockholm
Country
Sweden
Facility Name
Local Institution
City
Sundsvall
Country
Sweden
Facility Name
Local Institution
City
Bellinzona
Country
Switzerland
Facility Name
Local Institution
City
Liestal
Country
Switzerland
Facility Name
Local Institution
City
Zuerich
Country
Switzerland
Facility Name
Local Institution
City
Glasgow
State/Province
Dumbartonshire
Country
United Kingdom
Facility Name
Local Institution
City
Romford
State/Province
Essex
Country
United Kingdom
Facility Name
Local Institution
City
Hull
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Local Institution
City
York
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Local Institution
City
Dundee
Country
United Kingdom
Facility Name
Local Institution
City
Londonderry
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19001508
Citation
Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
Results Reference
result
PubMed Identifier
20231531
Citation
Zile MR, Gaasch WH, Anand IS, Haass M, Little WC, Miller AB, Lopez-Sendon J, Teerlink JR, White M, McMurray JJ, Komajda M, McKelvie R, Ptaszynska A, Hetzel SJ, Massie BM, Carson PE; I-Preserve Investigators. Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial. Circulation. 2010 Mar 30;121(12):1393-405. doi: 10.1161/CIRCULATIONAHA.109.909614. Epub 2010 Mar 15.
Results Reference
result
PubMed Identifier
18279770
Citation
McMurray JJ, Carson PE, Komajda M, McKelvie R, Zile MR, Ptaszynska A, Staiger C, Donovan JM, Massie BM. Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial. Eur J Heart Fail. 2008 Feb;10(2):149-56. doi: 10.1016/j.ejheart.2007.12.010.
Results Reference
result
PubMed Identifier
16230259
Citation
Carson P, Massie BM, McKelvie R, McMurray J, Komajda M, Zile M, Ptaszynska A, Frangin G; I-PRESERVE Investigators. The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design. J Card Fail. 2005 Oct;11(8):576-85. doi: 10.1016/j.cardfail.2005.06.432.
Results Reference
result
PubMed Identifier
20142024
Citation
McKelvie RS, Komajda M, McMurray J, Zile M, Ptaszynska A, Donovan M, Carson P, Massie BM; I-Preserve Investigators. Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial. J Card Fail. 2010 Feb;16(2):128-34. doi: 10.1016/j.cardfail.2009.09.007. Epub 2009 Nov 4.
Results Reference
result
PubMed Identifier
33301080
Citation
Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.
Results Reference
derived
PubMed Identifier
31370950
Citation
Tromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.
Results Reference
derived
PubMed Identifier
30871349
Citation
Kristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766.
Results Reference
derived
PubMed Identifier
28052977
Citation
Kristensen SL, Mogensen UM, Jhund PS, Petrie MC, Preiss D, Win S, Kober L, McKelvie RS, Zile MR, Anand IS, Komajda M, Gottdiener JS, Carson PE, McMurray JJ. Clinical and Echocardiographic Characteristics and Cardiovascular Outcomes According to Diabetes Status in Patients With Heart Failure and Preserved Ejection Fraction: A Report From the I-Preserve Trial (Irbesartan in Heart Failure With Preserved Ejection Fraction). Circulation. 2017 Feb 21;135(8):724-735. doi: 10.1161/CIRCULATIONAHA.116.024593. Epub 2017 Jan 4.
Results Reference
derived
PubMed Identifier
27317843
Citation
Gandhi PU, Chow SL, Rector TS, Krum H, Gaggin HK, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Carson PE, Januzzi JL Jr, Anand IS. Prognostic Value of Insulin-Like Growth Factor-Binding Protein 7 in Patients with Heart Failure and Preserved Ejection Fraction. J Card Fail. 2017 Jan;23(1):20-28. doi: 10.1016/j.cardfail.2016.06.006. Epub 2016 Jun 16.
Results Reference
derived
PubMed Identifier
26067854
Citation
Badar AA, Perez-Moreno AC, Hawkins NM, Jhund PS, Brunton AP, Anand IS, McKelvie RS, Komajda M, Zile MR, Carson PE, Gardner RS, Petrie MC, McMurray JJ. Clinical Characteristics and Outcomes of Patients With Coronary Artery Disease and Angina: Analysis of the Irbesartan in Patients With Heart Failure and Preserved Systolic Function Trial. Circ Heart Fail. 2015 Jul;8(4):717-24. doi: 10.1161/CIRCHEARTFAILURE.114.002024. Epub 2015 Jun 11.
Results Reference
derived
PubMed Identifier
25225241
Citation
Oluleye OW, Rector TS, Win S, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Massie B, Carson PE, Anand IS. History of atrial fibrillation as a risk factor in patients with heart failure and preserved ejection fraction. Circ Heart Fail. 2014 Nov;7(6):960-6. doi: 10.1161/CIRCHEARTFAILURE.114.001523. Epub 2014 Sep 15.
Results Reference
derived
PubMed Identifier
24864045
Citation
Bohm M, Perez AC, Jhund PS, Reil JC, Komajda M, Zile MR, McKelvie RS, Anand IS, Massie BM, Carson PE, McMurray JJ; I-Preserve Committees and Investigators. Relationship between heart rate and mortality and morbidity in the irbesartan patients with heart failure and preserved systolic function trial (I-Preserve). Eur J Heart Fail. 2014 Jul;16(7):778-87. doi: 10.1002/ejhf.85. Epub 2014 May 23.
Results Reference
derived
PubMed Identifier
22887722
Citation
Lam CS, Carson PE, Anand IS, Rector TS, Kuskowski M, Komajda M, McKelvie RS, McMurray JJ, Zile MR, Massie BM, Kitzman DW. Sex differences in clinical characteristics and outcomes in elderly patients with heart failure and preserved ejection fraction: the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Circ Heart Fail. 2012 Sep 1;5(5):571-8. doi: 10.1161/CIRCHEARTFAILURE.112.970061. Epub 2012 Aug 10.
Results Reference
derived
PubMed Identifier
22267751
Citation
Rector TS, Carson PE, Anand IS, McMurray JJ, Zile MR, McKelvie RS, Komajda M, Kuskowski M, Massie BM; I-PRESERVE Trial Investigators. Assessment of long-term effects of irbesartan on heart failure with preserved ejection fraction as measured by the minnesota living with heart failure questionnaire in the irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial. Circ Heart Fail. 2012 Mar 1;5(2):217-25. doi: 10.1161/CIRCHEARTFAILURE.111.964221. Epub 2012 Jan 20.
Results Reference
derived
PubMed Identifier
22064591
Citation
Zile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.
Results Reference
derived
PubMed Identifier
21750125
Citation
Krum H, Elsik M, Schneider HG, Ptaszynska A, Black M, Carson PE, Komajda M, Massie BM, McKelvie RS, McMurray JJ, Zile MR, Anand IS. Relation of peripheral collagen markers to death and hospitalization in patients with heart failure and preserved ejection fraction: results of the I-PRESERVE collagen substudy. Circ Heart Fail. 2011 Sep;4(5):561-8. doi: 10.1161/CIRCHEARTFAILURE.110.960716. Epub 2011 Jul 12.
Results Reference
derived
PubMed Identifier
21715583
Citation
Anand IS, Rector TS, Cleland JG, Kuskowski M, McKelvie RS, Persson H, McMurray JJ, Zile MR, Komajda M, Massie BM, Carson PE. Prognostic value of baseline plasma amino-terminal pro-brain natriuretic peptide and its interactions with irbesartan treatment effects in patients with heart failure and preserved ejection fraction: findings from the I-PRESERVE trial. Circ Heart Fail. 2011 Sep;4(5):569-77. doi: 10.1161/CIRCHEARTFAILURE.111.962654. Epub 2011 Jun 29.
Results Reference
derived
PubMed Identifier
21350053
Citation
Haass M, Kitzman DW, Anand IS, Miller A, Zile MR, Massie BM, Carson PE. Body mass index and adverse cardiovascular outcomes in heart failure patients with preserved ejection fraction: results from the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Circ Heart Fail. 2011 May;4(3):324-31. doi: 10.1161/CIRCHEARTFAILURE.110.959890. Epub 2011 Feb 24.
Results Reference
derived
PubMed Identifier
21068341
Citation
Komajda M, Carson PE, Hetzel S, McKelvie R, McMurray J, Ptaszynska A, Zile MR, Demets D, Massie BM. Factors associated with outcome in heart failure with preserved ejection fraction: findings from the Irbesartan in Heart Failure with Preserved Ejection Fraction Study (I-PRESERVE). Circ Heart Fail. 2011 Jan;4(1):27-35. doi: 10.1161/CIRCHEARTFAILURE.109.932996. Epub 2010 Nov 10.
Results Reference
derived

Learn more about this trial

Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)

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