(Applicant?s Abstract) The primary aim of ACTION is to determine the long-term safety and efficacy of exercise training for New York Heart Association Classes II-IV congestive heart failure patients in addition to standard of care versus a strategy of standard care alone. The secondary objective is to determine the incidence and significance of exercise-related complications. As part of this objective, the investigators will determine the specific characteristics of patients with increased benefit or increased risk from exercise. The exercise training will include 36 supervised training sessions followed by home exercise and interval supervised sessions. Training will be at 60-70% of peak VO2. Efficacy will be defined as the primary combined endpoint of all-cause mortality and all-cause hospitalizations. These clinical endpoints will be supported by physiological, resource utilization, and quality-of-life endpoints. The expected annual baseline rate is 30% for the control group. The expected dropout rate is 35% for the first year and 15%, with a cross-over rate of 5% per year. Using these assumptions, a total sample size of 3000 subjects will be required to detect a 20% reduction in the primary outcome with an alpha level of 0.05 and a power of 80%. The trial will take place over 5 years with an initial 6 months for finalizing the study and training the Regional Centers, 3 years of enrollment, 1 year of follow-up, and 6 months for close out, analysis and presentation.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HL066491-01A1
Application #
6261366
Study Section
Special Emphasis Panel (ZHL1-CSR-A (O1))
Program Officer
Cooper, Lawton S
Project Start
2002-09-30
Project End
2006-07-31
Budget Start
2002-09-30
Budget End
2003-07-31
Support Year
1
Fiscal Year
2002
Total Cost
$169,809
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
Levy, Wayne C; Li, Yanhong; Reed, Shelby D et al. (2017) Does the Implantable Cardioverter-Defibrillator Benefit Vary With the Estimated Proportional Risk of Sudden Death in Heart Failure Patients? JACC Clin Electrophysiol 3:291-298
Zeitler, Emily P; Piccini, Jonathan P; Hellkamp, Anne S et al. (2015) Exercise training and pacing status in patients with heart failure: results from HF-ACTION. J Card Fail 21:60-7
Li, Yanhong; Levy, Wayne C; Neilson, Matthew P et al. (2014) Associations between seattle heart failure model scores and medical resource use and costs: findings from HF-ACTION. J Card Fail 20:541-7
Jones, Lee W; Douglas, Pamela S; Khouri, Michel G et al. (2014) Safety and efficacy of aerobic training in patients with cancer who have heart failure: an analysis of the HF-ACTION randomized trial. J Clin Oncol 32:2496-502
Li, Yanhong; Neilson, Matthew P; Whellan, David J et al. (2013) Associations between Seattle Heart Failure Model scores and health utilities: findings from HF-ACTION. J Card Fail 19:311-6
McCullough, Peter A; Barnard, Denise; Clare, Robert et al. (2013) Anemia and associated clinical outcomes in patients with heart failure due to reduced left ventricular systolic function. Clin Cardiol 36:611-20
Blumenthal, James A; Babyak, Michael A; O'Connor, Christopher et al. (2012) Effects of exercise training on depressive symptoms in patients with chronic heart failure: the HF-ACTION randomized trial. JAMA 308:465-74
Gardin, Julius M; Leifer, Eric S; Kitzman, Dalane W et al. (2012) Usefulness of Doppler echocardiographic left ventricular diastolic function and peak exercise oxygen consumption to predict cardiovascular outcomes in patients with systolic heart failure (from HF-ACTION). Am J Cardiol 110:862-9
Flynn, Kathryn E; Lin, Li; Moe, Gordon W et al. (2012) Relationships between changes in patient-reported health status and functional capacity in outpatients with heart failure. Am Heart J 163:88-94.e3
Reed, Shelby D; Li, Yanhong; Dunlap, Mark E et al. (2012) In-hospital resource use and medical costs in the last year of life by mode of death (from the HF-ACTION randomized controlled trial). Am J Cardiol 110:1150-5

Showing the most recent 10 out of 23 publications