# HF-ACTION

Study · id `cardio:hf-action` · Cardiovascular Atlas · release `73130c34862e2d06` (public)

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

Browse, organ or system: Heart  
Browse, condition area: Heart failure; Acute care and long-term living  

## In plain language

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.

## 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.

## Key facts

- 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: 2331 participants (enrolled count; Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, snapshot `cardio:ctgov-nct00047437-2026-10-15`, retrieved 2026-10-15)
- Started: 2003-04 (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, snapshot `cardio:ctgov-nct00047437-2026-10-15`, retrieved 2026-10-15)
- Primary completion: 2008-07 (actual) (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, snapshot `cardio:ctgov-nct00047437-2026-10-15`, retrieved 2026-10-15)
- Completion: 2008-07 (actual) (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, snapshot `cardio:ctgov-nct00047437-2026-10-15`, retrieved 2026-10-15)
- Countries: United States; Canada; France (Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure, snapshot `cardio:ctgov-nct00047437-2026-10-15`, retrieved 2026-10-15)
- 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, snapshot `cardio:pubmed-19351941-2026-10-15`, retrieved 2026-10-15)
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct00047437-2026-10-15`, retrieved 2026-10-15)

## Claims, with the population each applies to

## 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).

### 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.

- Category: Effect
- Evidence stage: Interventional
- Certainty: Certainty not assessed
- Applies to: 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).
- 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
- Sources:
  1. Supports: Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1001/jama.2009.454>
     Locator: Abstract, RESULTS, sentences 4 and 5. Retrieved 2026-10-15T13:48:12Z. Source state: Current. Snapshot hash: c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed.
     How it applies: Primary and secondary end point results.
  2. Supports: Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1001/jama.2009.454>
     Locator: Abstract, RESULTS, sentence 6. Retrieved 2026-10-15T13:48:12Z. Source state: Current. Snapshot hash: c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed.
     How it applies: Prespecified supplementary adjusted analyses.
  3. Supports: Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1001/jama.2009.454>
     Locator: Abstract, RESULTS, sentences 3 and 7. Retrieved 2026-10-15T13:48:12Z. Source state: Current. Snapshot hash: c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed.
     How it applies: Exercise adherence and other adverse events.
  4. Background: Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1001/jama.2009.454>
     Locator: Abstract, DESIGN, SETTING, AND PATIENTS; INTERVENTIONS. Retrieved 2026-10-15T13:48:12Z. Source state: Current. Snapshot hash: c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed.
     How it applies: Design, centers, follow-up and what the groups received.
  5. Background: Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial (Publication, edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched.) <https://doi.org/10.1001/jama.2009.454>
     Locator: Abstract, CONCLUSIONS, sentences 1 and 2. Retrieved 2026-10-15T13:48:12Z. Source state: Current. Snapshot hash: c4fb52f8e24ff924f03adb41660c365dd15410ae4c2196613d4f728ac1692aed.
     How it applies: The authors' conclusions.

## Connected pages

- Studies people with this condition: Heart failure (`cardio:heart-failure`)
- Collaborator on the registry record: National Heart, Lung, and Blood Institute (`cardio:nhlbi`)

## Provenance

Content hash: 273b3ff560933f4b46118c1df0325b0f610305a151cf05d71bba847adf775be4
Last substantive edit: 2026-10-15
Evidence last checked: 2026-10-15