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Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Supervised Exercise Training Program
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

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

Inclusion Criteria: LVEF less than or equal to 35% New York Heart Association (NYHA) class II, III, or IV CHF diagnosis in the 3 months prior to study entry, with a minimum of 6 weeks of treatment Must be on optimal heart failure therapy according to American Heart Association (AHA), American College of Cardiology (ACC), and Heart Failure Society of America (HFSA) heart failure guidelines, including treatment with angiotensin II converting enzyme inhibitors (ACEI) and beta-blocker therapy, or have documentation justifying why optimal therapy is not being used, including intolerance, contraindication, participant preference, or physician's judgment Must be on stable doses of medications (e.g., beta-blocker, ACEI, and additional medications as listed in the study guidelines) for 6 weeks prior to study entry Must be in stable medical condition and able to begin an exercise program, as determined by study physician Exclusion Criteria: Comorbid disease, behavioral limitations, or other limitations that would interfere with exercise training, or would prevent completion of 1 year of exercise training Pregnant or planning to become pregnant in the year following study entry Major heart event or heart procedure within the 6 weeks prior to study entry Heart procedure or hospitalization for any reason planned in the future Expecting to receive a heart transplant in the 6 months following study entry CHF caused by significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction); if valve replacement has been performed, may not participate for 12 months following the procedure CHF caused by congenital heart disease or obstructive cardiomyopathy Performance of exercise training at regular intervals (more than once per week) at a moderate to vigorous intensity at any time in the 6 weeks prior to study entry Exercise testing results that would prevent safe exercise training, as defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines, including abnormal blood pressure response, early ischemic changes, and unexpected life-threatening arrhythmia Use of fixed-rate pacemakers, pacemakers with inability to attain target heart rates, or automatic implantable cardioverter defibrillator (AICD) devices with heart rate limits set below the target heart rate for exercise training Use of an intracardiac device such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy pacemaker in the 6 months prior to study entry (must demonstrate stability for 6 weeks post-procedure) Primary physician considers placement of an intracardiac device such as an ICD or a cardiac resynchronization therapy pacemaker probable within 6 months of study entry; will be excluded until such device has been placed and 6 weeks of stabilization have passed Participation in another clinical trial that may interfere with study participation, follow-up, or data collection, or that may affect cardiovascular morbidity or mortality

Sites / Locations

  • University of Alabama at Birmingham
  • Heart Clinic Arkansas
  • Memorial Heart Institute
  • Ahmanson-University of California Los Angeles
  • University of California, Davis Medical Center
  • University of California at San Diego Medical Center
  • University of Colorado Health Sciences Center
  • Heart and Vascular Clinic of Northern Colorado
  • Hartford Hospital
  • Veterans Affairs Medical Center
  • Southwest Florida Heart Group
  • University of Florida
  • Mayo Clinic
  • Morehouse School of Medicine
  • Emory University Hospital
  • Cardiovascular Associates of Augusta
  • Heart and Lung Group of Savannah
  • Northwestern University Medical Center
  • University of Chicago Hospitals
  • Central DuPage Hospital
  • The Care Group, LLC
  • University of Iowa Hospital and Clinics
  • University of Louisville
  • Ochsner Clinic Foundation
  • University of Maryland
  • Johns Hopkins University Medical Center
  • Boston Medical Center
  • Brigham and Women's Hospital
  • Henry Ford Hospital
  • Saint John Hospital and Medical Center
  • William Beaumont Hospital
  • University of Minnesota
  • Mayo Clinic
  • Mid America Heart Institute-Saint Luke's Hospital
  • Washington University School of Medicine
  • Glacier View Cardiology, P.C.
  • Bryan Lincoln General Hospital
  • University of Medicine & Dentistry of New Jersey
  • Hackensack University Medical Center
  • University of New Mexico
  • University of Rochester
  • Saint Francis Hospital
  • University of North Carolina School of Medicine
  • Northeast Medical Center
  • Duke University Medical Center
  • Wake Forest University School of Medicine
  • University of Cincinnati
  • University Hospitals of Cleveland
  • Davis Heart and Lung Research Institute
  • Medical University of Ohio
  • University of Oklahoma Health Sciences Center
  • Oregon Health & Sciences University
  • Geisinger Medical Center
  • University of Pennsylvania
  • Temple University Hospital
  • University of Pittsburgh Medical Center
  • Saint Thomas Hospital
  • Vanderbilt University Medical Center
  • Medical City Dallas Hospital
  • Baylor Heart and Vascular Hospital
  • LDS Hospital
  • Lynchburg General Hospital
  • University of Washington Medical Center
  • University of Wisconsin Madison
  • Aurora Health Care
  • University of Calgary
  • University of Manitoba Health Sciences Center
  • Queen Elizabeth II Health Sciences Center
  • Hamilton General Hospital
  • London Health Sciences Center
  • Saint Michaels Hospital
  • Toronto General Hospital
  • Montreal Heart Institute
  • Laval Hospital
  • CHU de Caen
  • Hopital Beaujon Cardiologie
  • Hopital Henri Mondor-Service de C
  • Hopital Broussais
  • Centre Cardiologie du Nord
  • Hopital Brabois

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

2

1

Arm Description

Outcomes

Primary Outcome Measures

Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3)

Secondary Outcome Measures

Changes in peak VO2
Changes in VE/VCO2 slope
Heart rate at a submaximal work load defined as the end of the exercise test's second stage
Changes in 6-minute walk (measured at Month 3 and Year 1)
Composite of cardiovascular mortality and cardiovascular hospitalization rates
Composite of cardiovascular mortality and CHF hospitalization rates
All-cause mortality rates
Cardiovascular mortality rates
All-cause hospitalization rates
CHF hospitalization rates
Heart attack rates
Worsening CHF event rates
Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates
Cost
Quality of life

Full Information

First Posted
October 3, 2002
Last Updated
March 20, 2013
Sponsor
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00047437
Brief Title
Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure
Official Title
Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2003 (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
Duke University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).
Detailed Description
BACKGROUND: CHF affects approximately five million Americans and is the number one cause of hospital admission in individuals over the age of 65. Although exercise training improves several clinical measures in individuals with CHF (e.g., peak VO2, heart rate variability, and plasma norepinephrine levels), it is not known whether exercise training reduces mortality in individuals with CHF. DESIGN NARRATIVE: This multicenter randomized study will determine if exercise training reduces mortality and hospitalization rates in individuals with moderate to severe CHF. The secondary objective is to evaluate whether an exercise program designed for individuals with CHF improves quality of life and functioning, is economically advantageous, and prevents medical complications. Three thousand individuals with moderate to severe CHF will be randomly assigned to either standard medical therapy and education, or standard medical therapy and education plus a supervised exercise training program. The exercise training will include 36 supervised clinic-based training sessions followed by home-based exercise and periodic supervised sessions for reinforcement. Participants assigned to the supervised exercise training program will use either a treadmill or stationary bicycle, which will be provided for them. Recruitment Status: As of November 9, 2006, HF-ACTION has enrolled 2180 subjects and will conclude enrollment at the end of February, 2007, with an anticipated enrollment of approximately 2300 subjects.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2331 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Active Comparator
Arm Title
1
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Supervised Exercise Training Program
Intervention Description
Exercise 30 minutes minimum three times per week.
Primary Outcome Measure Information:
Title
Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3)
Time Frame
Measured as events occur during the lifespan of the trial.
Secondary Outcome Measure Information:
Title
Changes in peak VO2
Time Frame
Measured at 3 months, 12 months, and 24 months.
Title
Changes in VE/VCO2 slope
Time Frame
Measured at 3 months, 12 months, and 24 months.
Title
Heart rate at a submaximal work load defined as the end of the exercise test's second stage
Time Frame
Measured at 3 months, 12 months, and 24 months.
Title
Changes in 6-minute walk (measured at Month 3 and Year 1)
Time Frame
Measured at 3 months, 12 months, 24 months, 36 months, and at end of study.
Title
Composite of cardiovascular mortality and cardiovascular hospitalization rates
Time Frame
Measured as events occur during the life of the trial.
Title
Composite of cardiovascular mortality and CHF hospitalization rates
Time Frame
Measured as events occur during the life of the trial.
Title
All-cause mortality rates
Time Frame
Measured as events occur during the life of the trial.
Title
Cardiovascular mortality rates
Time Frame
Measured as events occur during the life of the trial.
Title
All-cause hospitalization rates
Time Frame
Measured as events occur during the life of the trial.
Title
CHF hospitalization rates
Time Frame
Measured as events occur during the life of the trial.
Title
Heart attack rates
Time Frame
Measured as events occur during the life of the trial.
Title
Worsening CHF event rates
Time Frame
Measured as events occur during the life of the trial.
Title
Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates
Time Frame
Measured as events occur during the life of the trial.
Title
Cost
Time Frame
Measured throughout the life of the trial.
Title
Quality of life
Time Frame
Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: LVEF less than or equal to 35% New York Heart Association (NYHA) class II, III, or IV CHF diagnosis in the 3 months prior to study entry, with a minimum of 6 weeks of treatment Must be on optimal heart failure therapy according to American Heart Association (AHA), American College of Cardiology (ACC), and Heart Failure Society of America (HFSA) heart failure guidelines, including treatment with angiotensin II converting enzyme inhibitors (ACEI) and beta-blocker therapy, or have documentation justifying why optimal therapy is not being used, including intolerance, contraindication, participant preference, or physician's judgment Must be on stable doses of medications (e.g., beta-blocker, ACEI, and additional medications as listed in the study guidelines) for 6 weeks prior to study entry Must be in stable medical condition and able to begin an exercise program, as determined by study physician Exclusion Criteria: Comorbid disease, behavioral limitations, or other limitations that would interfere with exercise training, or would prevent completion of 1 year of exercise training Pregnant or planning to become pregnant in the year following study entry Major heart event or heart procedure within the 6 weeks prior to study entry Heart procedure or hospitalization for any reason planned in the future Expecting to receive a heart transplant in the 6 months following study entry CHF caused by significant uncorrected primary valvular disease (except mitral regurgitation secondary to left ventricular dysfunction); if valve replacement has been performed, may not participate for 12 months following the procedure CHF caused by congenital heart disease or obstructive cardiomyopathy Performance of exercise training at regular intervals (more than once per week) at a moderate to vigorous intensity at any time in the 6 weeks prior to study entry Exercise testing results that would prevent safe exercise training, as defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines, including abnormal blood pressure response, early ischemic changes, and unexpected life-threatening arrhythmia Use of fixed-rate pacemakers, pacemakers with inability to attain target heart rates, or automatic implantable cardioverter defibrillator (AICD) devices with heart rate limits set below the target heart rate for exercise training Use of an intracardiac device such as an implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy pacemaker in the 6 months prior to study entry (must demonstrate stability for 6 weeks post-procedure) Primary physician considers placement of an intracardiac device such as an ICD or a cardiac resynchronization therapy pacemaker probable within 6 months of study entry; will be excluded until such device has been placed and 6 weeks of stabilization have passed Participation in another clinical trial that may interfere with study participation, follow-up, or data collection, or that may affect cardiovascular morbidity or mortality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher M. O'Connor
Organizational Affiliation
Duke University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David J. Whellan
Organizational Affiliation
Jefferson Medical College of Thomas Jefferson University
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Heart Clinic Arkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Memorial Heart Institute
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Ahmanson-University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California at San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Heart and Vascular Clinic of Northern Colorado
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
Facility Name
Veterans Affairs Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Southwest Florida Heart Group
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33919
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Morehouse School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Cardiovascular Associates of Augusta
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Heart and Lung Group of Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Northwestern University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Central DuPage Hospital
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
The Care Group, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1081
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120-1613
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Saint John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Mid America Heart Institute-Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Glacier View Cardiology, P.C.
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Bryan Lincoln General Hospital
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
University of Medicine & Dentistry of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Hackensack University Medical Center
City
Westwood
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14624
Country
United States
Facility Name
Saint Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Facility Name
University of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
17517
Country
United States
Facility Name
Northeast Medical Center
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0542
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Davis Heart and Lung Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1252
Country
United States
Facility Name
Medical University of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614-2598
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Saint Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Baylor Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75426
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Lynchburg General Hospital
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6310
Country
United States
Facility Name
University of Wisconsin Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Manitoba Health Sciences Center
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Queen Elizabeth II Health Sciences Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K6A3
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
London Health Sciences Center
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Saint Michaels Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1N6
Country
Canada
Facility Name
Laval Hospital
City
Sainte Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Hopital Beaujon Cardiologie
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Hopital Henri Mondor-Service de C
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Broussais
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Centre Cardiologie du Nord
City
Saint Denis
ZIP/Postal Code
93200
Country
France
Facility Name
Hopital Brabois
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
17239677
Citation
Whellan DJ, O'Connor CM, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Houston-Miller N, Fleg JL, Schulman KA, Pina IL; HF-ACTION Trial Investigators. Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale. Am Heart J. 2007 Feb;153(2):201-11. doi: 10.1016/j.ahj.2006.11.007.
Results Reference
background
PubMed Identifier
34465123
Citation
Hejjaji V, Tang Y, Coles T, Jones PG, Reeve BB, Mentz RJ, Spatz ES, Dunlay SM, Caldwell B, Saha A, Tarver ME, Tran A, Patel KK, Henke D, Pina IL, Spertus JA. Psychometric Evaluation of the Kansas City Cardiomyopathy Questionnaire in Men and Women With Heart Failure. Circ Heart Fail. 2021 Sep;14(9):e008284. doi: 10.1161/CIRCHEARTFAILURE.120.008284. Epub 2021 Sep 1.
Results Reference
derived
PubMed Identifier
34344360
Citation
Truby LK, Regan JA, Giamberardino SN, Ilkayeva O, Bain J, Newgard CB, O'Connor CM, Felker GM, Kraus WE, McGarrah RW, Shah SH. Circulating long chain acylcarnitines and outcomes in diabetic heart failure: an HF-ACTION clinical trial substudy. Cardiovasc Diabetol. 2021 Aug 3;20(1):161. doi: 10.1186/s12933-021-01353-z.
Results Reference
derived
PubMed Identifier
33564986
Citation
Feng KY, O'Connor CM, Clare R, Alhanti B, Pina IL, Kraus WE, Whellan DJ, Mentz RJ. Greater Pain Severity Is Associated with Worse Outcomes in Patients with Heart Failure. J Cardiovasc Transl Res. 2021 Oct;14(5):984-991. doi: 10.1007/s12265-021-10104-0. Epub 2021 Feb 9.
Results Reference
derived
PubMed Identifier
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Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure

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