Cardiovascular Atlas
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HF-ACTION

A large trial of exercise training in adults with chronic heart failure and a reduced ejection fraction (the heart pumps out a smaller share of its blood). About half were assigned usual care plus a supervised exercise program (36 supervised sessions, then training at home) and half usual care alone. Over a median of 30 months, the planned main analysis (death or any hospital admission) did not show a significant difference between the groups. Analyses that adjusted for patients' baseline characteristics showed modest reductions. The trial ran at 82 centers in the United States, Canada and France.

Also called Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group trial of a supervised exercise training program added to usual care, compared with usual care alone, in medically stable outpatients with heart failure and reduced ejection fraction. The registry records masking as none and the primary purpose as prevention.
Phase
Not reported
Enrolled
  • 2,331 participants (enrolled count) (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT00047437
Started
(Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, retrieved )
Primary completion
(actual) (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, retrieved )
Completion
(actual) (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, retrieved )
Countries
United States, Canada, France (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, retrieved )
Care setting
Outpatient exercise training at 82 centers in the United States, Canada and France: 36 supervised sessions followed by home-based training (abstract). (Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Duke University-led randomized trial (NCT00047437) with the National Heart, Lung, and Blood Institute as a registry collaborator (sponsor edge below); registry phase 3, parallel groups, masking none, primary purpose prevention. 2331 enrolled (ClinicalTrials.gov gives no unit; the abstract counts patients). The registry labels its two arms "1" (no intervention) and "2" (active comparator) and names the intervention "Supervised Exercise Training Program". Start 2003-04, completion 2008-07; the abstract says patients were randomized from April 2003 through February 2007. The registry holds no results section. Numbers are on the claim. Only the PubMed abstract and the registry record were read.

Arms

  • Usual care plus aerobic exercise training

    Intervention None named

    Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training (abstract).

  • Usual care alone

    Intervention None named

    Usual care alone (abstract).

Findings

No findings are published for this study.

Claims and evidence

Context Medically stable outpatients with heart failure and reduced ejection fraction (HF-ACTION)

Recipient
Adult
Population
Medically stable outpatients with heart failure and reduced ejection fraction. The registry requires a left ventricular ejection fraction (LVEF) of 35% or less and New York Heart Association (NYHA) class II to IV heart failure. In the abstract, the median age was 59 years, 28% were women, 37% had NYHA class III or IV symptoms, and the median ejection fraction was 25%.
Care setting
Outpatient exercise training at 82 centers (abstract): supervised sessions followed by home-based training.
Geography
United States, Canada and France (abstract); the registry lists the same three countries.
Life stage
Adults; the registry gives a minimum age of 18 years and no maximum; the median age was 59 years in the abstract
Follow-up
Median follow-up of 30 months (abstract).
Eligibility: 2 inclusion criteria; 1 exclusion criterion
Included
  • LVEF of 35% or less (registry)
  • NYHA class II, III or IV heart failure diagnosed in the 3 months before study entry (registry)
Excluded
  • Comorbid disease, behavioral limitations or other limitations that would interfere with exercise training (registry)

  • Effect Interventional Certainty not assessed

    HF-ACTION randomly assigned 2331 medically stable outpatients with heart failure and reduced ejection fraction, at 82 centers in the United States, Canada and France, to usual care plus aerobic exercise training (36 supervised sessions followed by home-based training) or usual care alone; median follow-up was 30 months. In the protocol-specified primary analysis, 759 patients (65%) in the exercise training group died or were hospitalized, compared with 796 (68%) in the usual care group (hazard ratio 0.93, 95% CI 0.84 to 1.02; P = .13), so the trial did not show a significant reduction in its primary end point. The secondary end points also showed nonsignificant reductions: all-cause mortality 189 (16%) against 198 (17%) (hazard ratio 0.96, 95% CI 0.79 to 1.17; P = .70); cardiovascular mortality or cardiovascular hospitalization 632 (55%) against 677 (58%) (hazard ratio 0.92, 95% CI 0.83 to 1.03; P = .14); and cardiovascular mortality or heart failure hospitalization 344 (30%) against 393 (34%) (hazard ratio 0.87, 95% CI 0.75 to 1.00; P = .06). In prespecified supplementary analyses adjusted for highly prognostic baseline characteristics, the hazard ratios were 0.89 (95% CI 0.81 to 0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI 0.82 to 1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI 0.74 to 0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 to 74 minutes per week during months 10 through 12. Other adverse events were similar between the groups.

    Applies to Adult
    • Medically stable outpatients with heart failure and reduced ejection fraction. The registry requires a left ventricular ejection fraction (LVEF) of 35% or less and New York Heart Association (NYHA) class II to IV heart failure. In the abstract, the median age was 59 years, 28% were women, 37% had NYHA class III or IV symptoms, and the median ejection fraction was 25%.
    • Outpatient exercise training at 82 centers (abstract): supervised sessions followed by home-based training.
    • United States, Canada and France (abstract); the registry lists the same three countries.
    • Adults; the registry gives a minimum age of 18 years and no maximum; the median age was 59 years in the abstract
    Follow-up Median follow-up of 30 months (abstract).
    Certainty method
    Not assessed
    Limitations
    The adjusted results are supplementary analyses, and the authors describe the primary analysis as showing nonsignificant reductions; the adjusted reductions are described as modest. Patients had reduced ejection fraction (median 25%), a median age of 59 years, and 28% were women, so the result does not cover other groups. Exercise adherence fell over the first year. The registry lists no masking and holds no results section. Only the PubMed abstract and the registry record were read (the PMC copy is not in the open-access subset).
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (5)

    1. Supports Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial

      Publication · JAMA · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2009-04-08 · DOI: 10.1001/jama.2009.454 · PMID: 19351941 · PMCID: PMC2916661

      Locator
      Abstract, RESULTS, sentences 4 and 5
      How it applies
      Primary and secondary end point results.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial

      Publication · JAMA · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2009-04-08 · DOI: 10.1001/jama.2009.454 · PMID: 19351941 · PMCID: PMC2916661

      Locator
      Abstract, RESULTS, sentence 6
      How it applies
      Prespecified supplementary adjusted analyses.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial

      Publication · JAMA · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2009-04-08 · DOI: 10.1001/jama.2009.454 · PMID: 19351941 · PMCID: PMC2916661

      Locator
      Abstract, RESULTS, sentences 3 and 7
      How it applies
      Exercise adherence and other adverse events.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    4. Background Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial

      Publication · JAMA · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2009-04-08 · DOI: 10.1001/jama.2009.454 · PMID: 19351941 · PMCID: PMC2916661

      Locator
      Abstract, DESIGN, SETTING, AND PATIENTS; INTERVENTIONS
      How it applies
      Design, centers, follow-up and what the groups received.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    5. Background Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial

      Publication · JAMA · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2009-04-08 · DOI: 10.1001/jama.2009.454 · PMID: 19351941 · PMCID: PMC2916661

      Locator
      Abstract, CONCLUSIONS, sentences 1 and 2
      How it applies
      The authors' conclusions.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Record details

Record id
cardio:hf-action
Content hash
273b3ff560933f4b46118c1df0325b0f610305a151cf05d71bba847adf775be4