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JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.

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

Collaborators (303)

O'Connor CM, Lee KL, Ellis SJ, Rendall DS, Whellan DJ, Piña IL, Keteyian SJ, Cooper LS, Boineau R, Fine LJ, Fleg JL, Leifer ES, Erickson V, Howlett JG, Miller NH, Isaac D, McKelvie R, Zannad F, Boozer S, Connolly P, Doll A, Ellis SJ, Frazier C, Mark D, McClanahan-Crowder M, Meyer M, Mickley BS, Rendall DS, Rich M, Rostami H, Settles S, Spinella K, Staib J, Thompson O, Abraham W, Biniakiewicz D, Homan J, Bittner V, Fitz-Gerald M, Ewald G, Craddock H, Flanagan J, Fonarow G, Erickson V, Colucci W, Lim NZ, Tokareva E, Alharethi R, Hershberger R, Nauman D, Keteyian SJ, Saval M, Kitzman DW, Fray BL, Moore B, Piña IL, Vest M, Smith A, Snell G, Wolfel E, Cantu M, Adams K, Glotzer J, Johnson V, Schumacher K, Blackburn G, Geither C, Moore S, Chandler AB Jr, Vaughn SB, Easler PJ, Williams D, Gardin JM, Dimick K, Sklar SK, Teller S, Ghali JK, Hale-Stenson K, Gheorghiade M, Strzelczyk T, Johnson MR, Vander Ark C, Goldberg LR, Kao A, Dekerlegand J, Kraus WE, Johnson J, Duscha BD, Mehra MR, Ventura H, Harris B, Colvin-Adams M, Duderstadt K, Meyer K, Steger M, Cabuay B, Oren RM, Scovel P, Kao A, Stevens T, Haffey K, Mandacina C, Stewart A, Swank AM, Manire J, Thompson PD, Cosio-Lima L, Lagasse M, Naz T, Wagoner L, Roll SK, Yanowitz FG, Walker J, Mueller A, McCullough P, Coleman C, Dorrell KA, Washington T, Handberg E, Hill JA, Bakos J, Boyette A, Smith P, Williams C, Badenhop D, Schroeder S, Walter K, Kokkinos P, Collins E, Korsak L, Eichhorn E, Leonard A, Worley T, Fletcher G, Peasley P, Oldano P, Kostis J, Cosgrove NM, Thadani U, Rogan L, Thresher M, Turner J, Barnard D, Herman D, Contasti A, Sagerian M, Ofili E, Onwuanyi A, Nkemdiche S, Eisen H, Fitzpatrick J, Wald J, Wong J, Ellestad M, Kern L, Amsterdam EA, Burns MJ, Fedson S, Garg RK, Bennett P, Bond L, Chen L, Schrack J, Pearce D, Bond L, Palevo G, Serfass M, Forman D, Lopez MM, Talabi-Oates Y, Williams A, Truitte D, Baumann C, Adams J, Lawrence A, McNamara D, Gruendler E, Schneider V, Hutchins S, Hartwick A, Campbell P, Esposito M, Buchter C, Letterer RA, Taylor R, Wells C, Johnson B, Kaping B, Leathes S, O'Bryan J, Langley L, Hastings ET, Clancy C, Agruss N, Lawless C, Fortman R, McConnell TR, Wantz D, Walsh MN, Margiotti R, Russell S, Heck E, Lachmann J, Lippman D, McLaughlin J, Landzberg J, Mathus S, Cullinane DW, Voyles W, Lenz D, Kaczkowski S, David JL, Gillespie E, Keane-Richmond P, Krueger SK, Heiss L, Gottlieb S, Greenberg N, Gordon N, Parks E, Willoughby M, Kronenberg MW, Glenn J, Madison C, Arnold M, Smith JK, Azevedo E, Drobot G, Estrella-Holder E, Howlett J, Cooley-Warnell D, Yarn S, Isaac D, Grant J, Lyzun K, LeBlanc MH, Vienneau R, McKelvie RS, Beare L, Hancock J, Moe G, Golob D, Melvin K, Cymet A, Renton J, Nigam A, LaLonge J, Djaballah K, Aebehard P, Iliou MC, Sabatier R, Belin A, Cohen-Solal A, Hittinger L, Pitt B, Ades PA, Basta LL, Froelicher V, Hamel ME, Massie BM, Moyé L, Powell LH, Kraus WE, Johnson J, Piner L, Bensimhon D, Russell S, Gardin JM, Bess RL, Cohen GI, Keteyian SJ, Ehrman JK, Brawner CA, Miller NH, Blumenthal JA, Barbour K, Spruill TM, Marcus B, Raczynski J, Adams K, Donahue M, Felker M, Schulman KA, Weinfurt KP, Flynn KE, Reed S, Burnette A, Davidson-Ray L, Friedman JY, Li Y, Lin L, O'Neal B, Zile M, Johnson RH, Bensimhon DR, Bittner V, Boineau R, Dunlap ME, Kraus WE, O'Connor CM, Moe G, Wertheimer J, Whellan DJ.

Author information

  • 1Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA. oconn002@mc.duke.edu

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.

PMID:
19351941
[PubMed - indexed for MEDLINE]
PMCID:
PMC2916661
Free PMC Article

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