Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial - PubMed (original) (raw)

Randomized Controlled Trial

. 2009 Apr 8;301(14):1439-50.

doi: 10.1001/jama.2009.454.

David J Whellan, Kerry L Lee, Steven J Keteyian, Lawton S Cooper, Stephen J Ellis, Eric S Leifer, William E Kraus, Dalane W Kitzman, James A Blumenthal, David S Rendall, Nancy Houston Miller, Jerome L Fleg, Kevin A Schulman, Robert S McKelvie, Faiez Zannad, Ileana L Piña; HF-ACTION Investigators

Collaborators, Affiliations

Randomized Controlled Trial

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

Christopher M O'Connor et al. JAMA. 2009.

Abstract

Context: Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes.

Objective: To test the efficacy and safety of exercise training among patients with heart failure.

Design, setting, and patients: Multicenter, randomized controlled trial of 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months.

Interventions: Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone.

Main outcome measures: Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization.

Results: The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Heart failure etiology was ischemic in 51%, and median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 patients (65%) in the exercise training group died or were hospitalized compared with 796 patients (68%) in the usual care group (hazard ratio [HR], 0.93 [95% confidence interval {CI}, 0.84-1.02]; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 patients [16%] in the exercise training group vs 198 patients [17%] in the usual care group; HR, 0.96 [95% CI, 0.79-1.17]; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise training group vs 677 [58%] in the usual care group; HR, 0.92 [95% CI, 0.83-1.03]; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise training group vs 393 [34%] in the usual care group; HR, 0.87 [95% CI, 0.75-1.00]; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81-0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82-1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74-0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups.

Conclusions: In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization.

Trial registration: clinicaltrials.gov Identifier: NCT00047437.

PubMed Disclaimer

Figures

Figure 1

Figure 1

Flow of Participants Through the Trial

Figure 2

Figure 2

Time to All-Cause Death or All-Cause Hospitalization

Figure 3

Figure 3

Time to All-Cause Mortality

Figure 4

Figure 4

Subgroup Analysis of the Primary End Point

Figure 5

Figure 5

Time to Cardiovascular Mortality or Cardiovascular Hospitalization

Figure 6

Figure 6

Time to Cardiovascular Mortality or Heart Failure Hospitalization

Similar articles

Cited by

References

    1. Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005;112(12):e154–e235. - PubMed
    1. Curtis LH, Whellan DJ, Hammill BG, et al. Incidence and prevalence of heart failure in elderly persons, 1994–2003. Arch Intern Med. 2008;168(4):418–424. - PubMed
    1. Bristow MR, Saxon LA, Boehmer J, et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350(21):2140–2150. - PubMed
    1. Cleland JG, Daubert JC, Erdmann E, et al. The effect of cardiac resynchronization on morbidity and mortality in heart failure. N Engl J Med. 2005;352(15):1539–1549. - PubMed
    1. Konstam MA, Gheorghiade M, Burnett JC, Jr, et al. Effects of oral tolvaptan in patients hospitalized for worsening heart failure: the EVEREST Outcome Trial. JAMA. 2007;297(12):1319–1331. - PubMed

Publication types

MeSH terms

Grants and funding

LinkOut - more resources