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Guiding Evidence Based Therapy Using Biomarker Intensified Treatment (GUIDE-IT)

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Usual Care
Biomarker-guided care NT-proBNP
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or older
  • Most recent LVEF to be ≤ 40% by any method within 12 months of randomization.
  • High risk heart failure as defined by the following criteria:

A Heart Failure Event in the prior 12 months, defined as any one of the following:

  • HF Hospitalization
  • Treatment in the Emergency Department (or equivalent) for Heart Failure
  • Outpatient treatment for heart failure with intravenous diuretics

AND

  • NT-proBNP greater than 2000 pg/mL or BNP greater than 400 pg/mL at any time during the 30 days prior to randomization
  • Willing to provide informed consent

Exclusion Criteria:

  • Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days
  • Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device
  • Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy
  • Severe stenotic valvular disease
  • Anticipated heart transplantation or ventricular assist device within 12 months
  • Chronic inotropic therapy
  • Complex congenital heart disease
  • End stage renal disease with renal replacement therapy
  • Non cardiac terminal illness with expected survival less than 12 months
  • Women who are pregnant or planning to become pregnant
  • Inability to comply with planned study procedures
  • Enrollment or planned enrollment in another clinical trial

Sites / Locations

  • The Heart Center PC
  • Sutter Memorial Hospital
  • University of California San Diego Medical Center
  • Yale University School of Medicine
  • Holy Cross Medical Group
  • Holy Cross Hospital
  • Emory University
  • University Cardiology Associates, LLC
  • Fox Valley Clinical Research Center, LLC
  • Krannert Institute of Cardiology
  • University of Maryland
  • Metropolitan Cardiovascular Consultants
  • Massachusetts General Hospital
  • Beth Israel Medical Center
  • Pentucket Medical Associates
  • Mayo Clinic
  • Washington University School of Medicine
  • Dartmouth Hitchcock Medical Center
  • Cardiovascular Associates of the Delaware Valley
  • Robert Wood Johnson University Hospital
  • Cardiovascular Associates of the Delaware Valley
  • Bronx-Lebanon Hospital Center
  • Jacobi Medical Center
  • Albert Einstein University Hospital
  • New York Methodist Hospital
  • Saratoga Cardiology Associates
  • University of North Carolina at Chapel Hill
  • Novant Health Heart and Vascular Institute
  • Duke University Medical Center
  • LeBauer Cardiovascular Research Foundation
  • University of Cincinnati Medical Center
  • Cleveland Clinic Foundation
  • Capitol Area Research, LLC
  • Drexel University College of Medicine
  • Thomas Jefferson University Hospital
  • Allegheny-Singer Research Institute
  • AnMed Health Medical Center
  • University of Texas Southwestern Medical Center Dallas
  • Intermountain Medical Center
  • Cardiovascular Associates, Ltd.
  • Foothills Medical Centre
  • University of Alberta Hospital
  • Vancouver General Hospital
  • Saint Paul's Hospital
  • Hamilton Health Sciences
  • St. Michaels Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Usual Care

Biomarker-Guided Care

Arm Description

Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.

Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.

Outcomes

Primary Outcome Measures

CV Death or Heart Failure Hospitalization
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality

Secondary Outcome Measures

All-cause Mortality
All-cause mortality by treatment arm
Cumulative Morbidity
Days alive and not hospitalized for CV reasons
CV Death
CV death by treatment arm
Number of Hospitalizations for First Heart Failure
First Heart Failure Hospitalization
Number of Hospitalizations for Recurrent Heart Failure
Recurrent Heart Failure Hospitalization
Percentage of Patients With Moderate to Severe Depression
Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher.
Duke Activity Status Index (DASI)
The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
EQ-5D Health Index
The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).
EQ-5D Visual Analog Scale
The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Short Form-36 (SF-36) General Health Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Short Form-36 (SF-36) Mental Health Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Short Form-36 (SF-36) Social Functioning Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Short Form-36 (SF-36) Physiological Functioning Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Short Form-36 (SF-36) Vitality Subscale
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Resource Utilization
Observed Resource Use
Resource Utilization Cost
Observed Hospital-Based Cost.

Full Information

First Posted
September 12, 2012
Last Updated
November 10, 2017
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01685840
Brief Title
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment
Acronym
GUIDE-IT
Official Title
Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Project was stopped due to futility
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 20, 2016 (Actual)
Study Completion Date
September 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to determine the efficacy of a strategy of biomarker-guided therapy compared with usual care in high risk patients with left ventricular systolic dysfunction.
Detailed Description
Heart failure is a common disorder in which the heart cannot pump enough blood to meet the needs of the rest of the body. Common symptoms of heart failure include shortness of breath, swelling, and fatigue. Standard treatment for heart failure include diuretics to control fluid, as well as drugs called "neurohormonal antagonists" (such as beta-blockers and ACE-inhibitors) that help the heart work more efficiently and prevent worsening of heart function. Typically, doctors adjust these medicines based on their clinical judgment about what doses and combination will work best for you. We are testing whether the use of a blood test called NT-proBNP (which measures a hormone released by the heart) can help doctors do a better job of adjusting these heart failure medicines over time than clinical judgment alone.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
894 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Experimental
Arm Description
Usual Care group will receive standard heart failure treatment based on the doctor's best judgment and following the recommendation of current guidelines. This will typically include the use of medicines such as beta-blockers, ACE-inhibitors, and diuretics, all of which are approved, recommended treatments for heart failure.
Arm Title
Biomarker-Guided Care
Arm Type
Experimental
Arm Description
Device: Biomarker-Guided care NT-proBNP The Biomarker Guided Therapy group will receive the standard heart failure treatments. In addition, the doctor will use the results of a blood test called NT-proBNP to help adjust the treatments and drug doses.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Usual Care
Intervention Type
Device
Intervention Name(s)
Biomarker-guided care NT-proBNP
Intervention Description
Device: NT-proBNP
Primary Outcome Measure Information:
Title
CV Death or Heart Failure Hospitalization
Description
Composite of First Heart Failure Hospitalization or Cardiovascular Mortality
Time Frame
24 Months
Secondary Outcome Measure Information:
Title
All-cause Mortality
Description
All-cause mortality by treatment arm
Time Frame
24 months
Title
Cumulative Morbidity
Description
Days alive and not hospitalized for CV reasons
Time Frame
24 months
Title
CV Death
Description
CV death by treatment arm
Time Frame
24 months
Title
Number of Hospitalizations for First Heart Failure
Description
First Heart Failure Hospitalization
Time Frame
24 months
Title
Number of Hospitalizations for Recurrent Heart Failure
Description
Recurrent Heart Failure Hospitalization
Time Frame
24 months
Title
Percentage of Patients With Moderate to Severe Depression
Description
Percentage of patients with moderate to severe depression as measured by the Center for Epidemiologic Studies Depression Scale (CES-D). CES-D is a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. Moderate to severe depression is indicated by a score of 11 or higher.
Time Frame
Baseline, 3,6, 12 and 24 months
Title
Duke Activity Status Index (DASI)
Description
The DASI is a self-administered questionnaire that measures a patient's functional capacity. It can be used to get a rough estimate of a patient's peak oxygen uptake. The maximum score for the DASI is 58.2 (better functional ability/capacity) and the minimum score is 0 (worse functional ability/capacity).
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
EQ-5D Health Index
Description
The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score, from -0.59 (worst) to 1 (best).
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
EQ-5D Visual Analog Scale
Description
The EQ-5D VAS records participants self-rated health status on a vertical (0-100) scale with higher scores indicating higher Health-Related Quality of Life, where 0 = worst imaginable health state and 100 = best imaginable health state.
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Score
Description
This KCCQ overall score represents the mean of the following 4 scores: Physical Limitation, Total Symptom, Quality of Life, and Social Limitation. Mean scores are transformed to a 0-100 scale with high scores representing better outcomes.
Time Frame
Baseline, 3, 6,12 and 24 months
Title
Short Form-36 (SF-36) General Health Subscale
Description
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Short Form-36 (SF-36) Mental Health Subscale
Description
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Short Form-36 (SF-36) Social Functioning Subscale
Description
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Short Form-36 (SF-36) Physiological Functioning Subscale
Description
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Short Form-36 (SF-36) Vitality Subscale
Description
SF-36 measures perceived Quality of Life. The following subscales were used: General Health, Mental Health, Social Functioning, Physiological Functioning, and Vitality Each subscale is scored from 0-100 with 0 indicating lowest quality of life.
Time Frame
Baseline, 3, 6, 12 and 24 months
Title
Resource Utilization
Description
Observed Resource Use
Time Frame
24 months
Title
Resource Utilization Cost
Description
Observed Hospital-Based Cost.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Most recent LVEF to be ≤ 40% by any method within 12 months of randomization. High risk heart failure as defined by the following criteria: A Heart Failure Event in the prior 12 months, defined as any one of the following: HF Hospitalization Treatment in the Emergency Department (or equivalent) for Heart Failure Outpatient treatment for heart failure with intravenous diuretics AND NT-proBNP greater than 2000 pg/mL or BNP greater than 400 pg/mL at any time during the 30 days prior to randomization Willing to provide informed consent Exclusion Criteria: Acute coronary syndrome (clinical diagnosis) or cardiac revascularization procedure within 30 days Cardiac resynchronization therapy (CRT) within prior 3 months or current plan to implant CRT device Active myocarditis, Hypertrophic obstructive cardiomyopathy, pericarditis, or restrictive cardiomyopathy Severe stenotic valvular disease Anticipated heart transplantation or ventricular assist device within 12 months Chronic inotropic therapy Complex congenital heart disease End stage renal disease with renal replacement therapy Non cardiac terminal illness with expected survival less than 12 months Women who are pregnant or planning to become pregnant Inability to comply with planned study procedures Enrollment or planned enrollment in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Felker, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Heart Center PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Sutter Memorial Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Holy Cross Medical Group
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University Cardiology Associates, LLC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Fox Valley Clinical Research Center, LLC
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Krannert Institute of Cardiology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Metropolitan Cardiovascular Consultants
City
Beltsville
State/Province
Maryland
ZIP/Postal Code
20705
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Pentucket Medical Associates
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
San Luis
State/Province
Missouri
ZIP/Postal Code
63112
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Cardiovascular Associates of the Delaware Valley
City
Sewell
State/Province
New Jersey
ZIP/Postal Code
08080
Country
United States
Facility Name
Bronx-Lebanon Hospital Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Albert Einstein University Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
New York Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Saratoga Cardiology Associates
City
Saratoga Springs
State/Province
New York
ZIP/Postal Code
12866
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Novant Health Heart and Vascular Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
LeBauer Cardiovascular Research Foundation
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Capitol Area Research, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny-Singer Research Institute
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
AnMed Health Medical Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
University of Texas Southwestern Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Cardiovascular Associates, Ltd.
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Saint Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Michaels Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada

12. IPD Sharing Statement

Citations:
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34784657
Citation
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Results Reference
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PubMed Identifier
34166799
Citation
Chouairi F, Fuery MA, Mullan CW, Caraballo C, Sen S, Maulion C, Wilkinson ST, Surti T, McCullough M, Miller PE, Pacor J, Leifer ES, Felker GM, Velazquez EJ, Fiuzat M, O'Connor CM, Januzzi JL, Desai NR, Ahmad T. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial. J Card Fail. 2021 Dec;27(12):1359-1366. doi: 10.1016/j.cardfail.2021.06.008. Epub 2021 Jun 22.
Results Reference
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PubMed Identifier
33992564
Citation
Fuery MA, Chouairi F, Januzzi JL, Moe GW, Caraballo C, McCullough M, Miller PE, Reinhardt SW, Clark K, Oseran A, Milner A, Pacor J, Kahn PA, Singh A, Ravindra N, Guha A, Vadlamani L, Kulkarni NS, Fiuzat M, Felker GM, O'Connor CM, Ahmad T, Ezekowitz J, Desai NR. Intercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure. JACC Heart Fail. 2021 Jul;9(7):497-505. doi: 10.1016/j.jchf.2021.02.011. Epub 2021 May 12.
Results Reference
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PubMed Identifier
33955231
Citation
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Results Reference
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PubMed Identifier
33754794
Citation
Parcha V, Patel N, Kalra R, Suri SS, Arora G, Wang TJ, Arora P. Obesity and Serial NT-proBNP Levels in Guided Medical Therapy for Heart Failure With Reduced Ejection Fraction: Insights From the GUIDE-IT Trial. J Am Heart Assoc. 2021 Apr 6;10(7):e018689. doi: 10.1161/JAHA.120.018689. Epub 2021 Mar 23.
Results Reference
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PubMed Identifier
32319999
Citation
Fiuzat M, Ezekowitz J, Alemayehu W, Westerhout CM, Sbolli M, Cani D, Whellan DJ, Ahmad T, Adams K, Pina IL, Patel CB, Anstrom KJ, Cooper LS, Mark D, Leifer ES, Felker GM, Januzzi JL, O'Connor CM. Assessment of Limitations to Optimization of Guideline-Directed Medical Therapy in Heart Failure From the GUIDE-IT Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2020 Jul 1;5(7):757-764. doi: 10.1001/jamacardio.2020.0640.
Results Reference
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PubMed Identifier
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Citation
Januzzi JL Jr, Ahmad T, Mulder H, Coles A, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Mark DB, Pina IL, Passmore G, Whellan DJ, Cooper LS, Leifer ES, Desvigne-Nickens P, Felker GM, O'Connor CM. Natriuretic Peptide Response and Outcomes in Chronic Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2019 Sep 3;74(9):1205-1217. doi: 10.1016/j.jacc.2019.06.055.
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PubMed Identifier
30919549
Citation
O'Connor C, Fiuzat M, Mulder H, Coles A, Ahmad T, Ezekowitz JA, Adams KF, Pina IL, Anstrom KJ, Cooper LS, Mark DB, Whellan DJ, Januzzi JL Jr, Leifer ES, Felker GM. Clinical factors related to morbidity and mortality in high-risk heart failure patients: the GUIDE-IT predictive model and risk score. Eur J Heart Fail. 2019 Jun;21(6):770-778. doi: 10.1002/ejhf.1450. Epub 2019 Mar 27.
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Citation
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Mark DB, Cowper PA, Anstrom KJ, Sheng S, Daniels MR, Knight JD, Baloch KN, Davidson-Ray L, Fiuzat M, Januzzi JL Jr, Whellan DJ, Pina IL, Ezekowitz JA, Adams KF, Cooper LS, O'Connor CM, Felker GM. Economic and Quality-of-Life Outcomes of Natriuretic Peptide-Guided Therapy for Heart Failure. J Am Coll Cardiol. 2018 Nov 27;72(21):2551-2562. doi: 10.1016/j.jacc.2018.08.2184.
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Felker GM, Anstrom KJ, Adams KF, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL Jr, Mark DB, Pina IL, Passmore G, Whellan DJ, Yang H, Cooper LS, Leifer ES, Desvigne-Nickens P, O'Connor CM. Effect of Natriuretic Peptide-Guided Therapy on Hospitalization or Cardiovascular Mortality in High-Risk Patients With Heart Failure and Reduced Ejection Fraction: A Randomized Clinical Trial. JAMA. 2017 Aug 22;318(8):713-720. doi: 10.1001/jama.2017.10565.
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PubMed Identifier
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Citation
Felker GM, Ahmad T, Anstrom KJ, Adams KF, Cooper LS, Ezekowitz JA, Fiuzat M, Houston-Miller N, Januzzi JL, Leifer ES, Mark DB, Desvigne-Nickens P, Paynter G, Pina IL, Whellan DJ, O'Connor CM. Rationale and design of the GUIDE-IT study: Guiding Evidence Based Therapy Using Biomarker Intensified Treatment in Heart Failure. JACC Heart Fail. 2014 Oct;2(5):457-65. doi: 10.1016/j.jchf.2014.05.007. Epub 2014 Sep 3.
Results Reference
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Guiding Evidence Based Therapy Using Biomarker Intensified Treatment

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