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Cardiovascular DiseasesPhase 3NCT00047437

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

A Phase 3 study testing Supervised Exercise Training Program in people with Cardiovascular Diseases and Heart Diseases, run by Duke University at 80 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Supervised Exercise Training Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,331 participants
Where
80 sitesin 3 countries
Study dates
Apr 2003to Jul 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

80 sites in 3 countries.

80 sites in 3 countries

United States65 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Morehouse School of Medicine

    Atlanta, Georgia, 30310

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Cardiovascular Associates of Augusta

    Augusta, Georgia, 30901

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University Medical Center

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120-1613

  • University of North Carolina School of Medicine

    Chapel Hill, North Carolina, 17517

  • Northwestern University Medical Center

    Chicago, Illinois, 60611

  • University of Chicago Hospitals

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0542

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Davis Heart and Lung Research Institute

    Columbus, Ohio, 43210-1252

  • Northeast Medical Center

    Concord, North Carolina, 28025

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Baylor Heart and Vascular Hospital

    Dallas, Texas, 75426

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • University of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Heart and Vascular Clinic of Northern Colorado

    Fort Collins, Colorado, 80528

  • Southwest Florida Heart Group

    Fort Myers, Florida, 33919

  • University of Florida

    Gainesville, Florida, 32610

  • Hartford Hospital

    Hartford, Connecticut, 06102-5037

  • The Care Group, LLC

    Indianapolis, Indiana, 46260

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa, 52242-1081

  • Mayo Clinic

    Jacksonville, Florida, 32216

  • Glacier View Cardiology, P.C.

    Kalispell, Montana, 59901

  • Mid America Heart Institute-Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Bryan Lincoln General Hospital

    Lincoln, Nebraska, 68516

  • Heart Clinic Arkansas

    Little Rock, Arkansas, 72205

  • Memorial Heart Institute

    Long Beach, California, 90806

  • Ahmanson-University of California Los Angeles

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40292

  • Lynchburg General Hospital

    Lynchburg, Virginia, 24501

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792

  • Aurora Health Care

    Milwaukee, Wisconsin, 53215

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Saint Thomas Hospital

    Nashville, Tennessee, 37205

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • University of Medicine & Dentistry of New Jersey

    New Brunswick, New Jersey, 08901

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Sciences University

    Portland, Oregon, 97239

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14624

  • Saint Francis Hospital

    Roslyn, New York, 11576

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • University of California at San Diego Medical Center

    San Diego, California, 92103

  • Heart and Lung Group of Savannah

    Savannah, Georgia, 31405

  • University of Washington Medical Center

    Seattle, Washington, 98195-6310

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Medical University of Ohio

    Toledo, Ohio, 43614-2598

  • Veterans Affairs Medical Center

    Washington D.C., District of Columbia, 20422

  • Hackensack University Medical Center

    Westwood, New Jersey, 07601

  • Central DuPage Hospital

    Winfield, Illinois, 60190

  • Wake Forest University School of Medicine

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada9 sites

  • University of Calgary

    Calgary, Alberta, T2N 4N1

  • Queen Elizabeth II Health Sciences Center

    Halifax, Nova Scotia, B3K6A3

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • London Health Sciences Center

    London, Ontario, N6A 4G5

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1N6

  • Laval Hospital

    Sainte-Foy, Quebec, G1V 4G5

  • Saint Michaels Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto General Hospital

    Toronto, Ontario, M5T 2S8

  • University of Manitoba Health Sciences Center

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

France6 sites

  • CHU de Caen

    Caen, 14000

  • Hopital Beaujon Cardiologie

    Clichy, 92110

  • Hopital Henri Mondor-Service de C

    Créteil, 94010

  • Hopital Broussais

    Paris, 75014

  • Centre Cardiologie du Nord

    Saint-Denis, 93200

  • Hopital Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)

The purpose of this study is to determine the long-term safety and effectiveness of exercise training for individuals with congestive heart failure (CHF).

Read the 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.

Being tested
Supervised Exercise Training Program
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised Exercise Training ProgramBehavioural

    Exercise 30 minutes minimum three times per week.

Study groups in NCT00047437
Study groupRoleWhat they receive
2Active comparatorNot described
Receives: Behavioral: Supervised Exercise Training Program
1No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Measured as events occur during the lifespan of the trial.

Secondary outcomes (15)

  1. Changes in peak VO2

    Measured: Measured at 3 months, 12 months, and 24 months.

  2. Changes in VE/VCO2 slope

    Measured: Measured at 3 months, 12 months, and 24 months.

  3. Heart rate at a submaximal work load defined as the end of the exercise test's second stage

    Measured: Measured at 3 months, 12 months, and 24 months.

  4. Changes in 6-minute walk (measured at Month 3 and Year 1)

    Measured: Measured at 3 months, 12 months, 24 months, 36 months, and at end of study.

  5. Composite of cardiovascular mortality and cardiovascular hospitalization rates

    Measured: Measured as events occur during the life of the trial.

  6. Composite of cardiovascular mortality and CHF hospitalization rates

    Measured: Measured as events occur during the life of the trial.

  7. All-cause mortality rates

    Measured: Measured as events occur during the life of the trial.

  8. Cardiovascular mortality rates

    Measured: Measured as events occur during the life of the trial.

  9. All-cause hospitalization rates

    Measured: Measured as events occur during the life of the trial.

  10. CHF hospitalization rates

    Measured: Measured as events occur during the life of the trial.

  11. Heart attack rates

    Measured: Measured as events occur during the life of the trial.

  12. Worsening CHF event rates

    Measured: Measured as events occur during the life of the trial.

  13. Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates

    Measured: Measured as events occur during the life of the trial.

  14. Cost

    Measured: Measured throughout the life of the trial.

  15. Quality of life

    Measured: Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2002 (estimated)
  2. Study startApr 2003
  3. Primary completionJul 2008
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047437
Sponsor's protocol ID
Pro00017406
Other IDs
U01HL063747, U01HL064250, U01HL064257, U01HL064264, U01HL064265, U01HL066461, U01HL066482, U01HL066491
Status last verified
Mar 2013
First submitted
3 Oct 2002
Last updated
21 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 17239677

  • Scheidegger C, Wandel S, Mutze T. Covariate Adjustment for the Win Odds: Application to Cardiovascular Outcomes Trials. Stat Med. 2026 May;45(10-12):e70602. doi: 10.1002/sim.70602.

    PubMed 42141513

  • 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.

    PubMed 34465123

  • 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.

    PubMed 34344360

  • 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.

    PubMed 33564986

  • Regan JA, Kitzman DW, Leifer ES, Kraus WE, Fleg JL, Forman DE, Whellan DJ, Wojdyla D, Parikh K, O'Connor CM, Mentz RJ. Impact of Age on Comorbidities and Outcomes in Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2019 Dec;7(12):1056-1065. doi: 10.1016/j.jchf.2019.09.004.

    PubMed 31779928

  • Mediano MFF, Leifer ES, Cooper LS, Keteyian SJ, Kraus WE, Mentz RJ, Fleg JL. Influence of Baseline Physical Activity Level on Exercise Training Response and Clinical Outcomes in Heart Failure: The HF-ACTION Trial. JACC Heart Fail. 2018 Dec;6(12):1011-1019. doi: 10.1016/j.jchf.2018.09.012.

    PubMed 30497641

  • Luo N, O'Connor CM, Cooper LB, Sun JL, Coles A, Reed SD, Whellan DJ, Pina IL, Kraus WE, Mentz RJ. Relationship between changing patient-reported outcomes and subsequent clinical events in patients with chronic heart failure: insights from HF-ACTION. Eur J Heart Fail. 2019 Jan;21(1):63-70. doi: 10.1002/ejhf.1299. Epub 2018 Aug 31.

    PubMed 30168635

  • Warraich HJ, O'Connor C, Wu A, Coles A, Kraus WE, Pina IL, Whellan DJ, Mentz RJ. Differences Between Patients Enrolled Early and Late During Clinical Trial Recruitment: Insights From the HF-ACTION Trial. Circ Cardiovasc Qual Outcomes. 2018 Jul;11(7):e004643. doi: 10.1161/CIRCOUTCOMES.117.004643. No abstract available.

    PubMed 29980656

  • Ambrosy AP, Bhatt AS, Stebbins AL, Wruck LM, Fudim M, Greene SJ, Kraus WE, O'Connor CM, Pina IL, Whellan DJ, Mentz RJ. Prevalent digoxin use and subsequent risk of death or hospitalization in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) randomized controlled trial. Am Heart J. 2018 May;199:97-104. doi: 10.1016/j.ahj.2018.02.004. Epub 2018 Feb 11.

    PubMed 29754673

  • Pokharel Y, Khariton Y, Tang Y, Nassif ME, Chan PS, Arnold SV, Jones PG, Spertus JA. Association of Serial Kansas City Cardiomyopathy Questionnaire Assessments With Death and Hospitalization in Patients With Heart Failure With Preserved and Reduced Ejection Fraction: A Secondary Analysis of 2 Randomized Clinical Trials. JAMA Cardiol. 2017 Dec 1;2(12):1315-1321. doi: 10.1001/jamacardio.2017.3983.

    PubMed 29094152

  • Sharma A, Stevens SR, Lucas J, Fiuzat M, Adams KF, Whellan DJ, Donahue MP, Kitzman DW, Pina IL, Zannad F, Kraus WE, O'Connor CM, Felker GM. Utility of Growth Differentiation Factor-15, A Marker of Oxidative Stress and Inflammation, in Chronic Heart Failure: Insights From the HF-ACTION Study. JACC Heart Fail. 2017 Oct;5(10):724-734. doi: 10.1016/j.jchf.2017.07.013.

    PubMed 28958347

  • Ambrosy AP, Cerbin LP, DeVore AD, Greene SJ, Kraus WE, O'Connor CM, Pina IL, Whellan DJ, Wojdyla D, Wu A, Mentz RJ. Aerobic exercise training and general health status in ambulatory heart failure patients with a reduced ejection fraction-Findings from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)trial. Am Heart J. 2017 Apr;186:130-138. doi: 10.1016/j.ahj.2016.12.017. Epub 2017 Jan 19.

    PubMed 28454828

  • Luo N, Merrill P, Parikh KS, Whellan DJ, Pina IL, Fiuzat M, Kraus WE, Kitzman DW, Keteyian SJ, O'Connor CM, Mentz RJ. Exercise Training in Patients With Chronic Heart Failure and Atrial Fibrillation. J Am Coll Cardiol. 2017 Apr 4;69(13):1683-1691. doi: 10.1016/j.jacc.2017.01.032.

    PubMed 28359513

  • Kelly JP, Dunning A, Schulte PJ, Fiuzat M, Leifer ES, Fleg JL, Cooper LS, Keteyian SJ, Kitzman DW, Pina IL, Kraus WE, Whellan DJ, O'Connor CM, Mentz RJ. Statins and Exercise Training Response in Heart Failure Patients: Insights From HF-ACTION. JACC Heart Fail. 2016 Aug;4(8):617-24. doi: 10.1016/j.jchf.2016.05.006. Epub 2016 Jul 6.

    PubMed 27395348

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Supervised Exercise Training Program in people with Cardiovascular Diseases and Heart Diseases, run by Duke University at 80 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Canada, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00047437, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.

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