ACTION - A CHF Trial Investigating Outcomes of Exercise

Summary

Principal Investigator: Gregg C Fonarow
Abstract: The primary aim of the ACTION Trial is to determine the long-term safety and effectiveness 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, the effect on exercise tolerance and quality of life, and the cost-effectiveness of training. The exercise training will include 36 facility-based training sessions followed by home-based exercise and interval facility sessions. Training will be at 60-70% of heart rate reserve. Patients randomized to the training arm will train by either walking or bicycle ergometers. Treadmills or exercise bicycles will be provided to training patients by the coordinating center, if desired. Effectiveness will be defined as the primary combined endpoint of all-cause mortality and all-cause hospitalizations. The expected annual baseline rate is 30% for the control group. The expected non-adherence and drop-out rate is 35% the first year and 15% annually thereafter, with a cross-over rate of 5% per year. The regional center team and the coordinating center will implement multiple strategies to improve adherence in patients in the training arm. 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 greater than 80%. If the non-adherence and drop-out rate decrease to 30% in the first year and 12.5% annually thereafter, the power to detect a 20% difference is greater than 90%. The primary analysis will be based on intent-to-treat. The trial will take place over 5 years with an initial 6 months for planning, training, and implementation; 3 years of enrollment; 1 year of follow-up; and 6 months for close out, analysis, and presentation.
Funding Period: 2002-09-30 - 2008-06-30
more information: NIH RePORT

Top Publications

  1. pmc Associations between Seattle Heart Failure Model scores and health utilities: findings from HF-ACTION
    Yanhong Li
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA
    J Card Fail 19:311-6. 2013
  2. pmc Associations between hemoglobin level, resource use, and medical costs in patients with heart failure: findings from HF-ACTION
    Shelby D Reed
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina 27715, USA
    J Card Fail 18:784-91. 2012
  3. pmc Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training
    Ann M Swank
    Exercise Physiology Laboratory University of Louisville, Louisville, KY 40292, USA
    Circ Heart Fail 5:579-85. 2012
  4. pmc In-hospital resource use and medical costs in the last year of life by mode of death (from the HF-ACTION randomized controlled trial)
    Shelby D Reed
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA
    Am J Cardiol 110:1150-5. 2012
  5. pmc Relationships between changes in patient-reported health status and functional capacity in outpatients with heart failure
    Kathryn E Flynn
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA
    Am Heart J 163:88-94.e3. 2012
  6. pmc Predicting maximal HR in heart failure patients on β-blockade therapy
    Steven J Keteyian
    Department of Internal Medicine, Henry Ford Hospital, Detroit, MI, USA
    Med Sci Sports Exerc 44:371-6. 2012
  7. pmc Economic evaluation of the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) randomized controlled trial: an exercise training study of patients with chronic heart failure
    Shelby D Reed
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA
    Circ Cardiovasc Qual Outcomes 3:374-81. 2010
  8. pmc Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure
    Kathryn E Flynn
    Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA
    Am Heart J 158:S64-71. 2009
  9. pmc Relationship of age and exercise performance in patients with heart failure: the HF-ACTION study
    Daniel E Forman
    Cardiovascular Division, Brigham and Women s Hospital, and Geriatric Research, Education, and Clinical Center GRECC, VA Boston Healthcare System, Boston, MA, USA
    Am Heart J 158:S6-S15. 2009
  10. pmc Myocardial perfusion, function, and dyssynchrony in patients with heart failure: baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Tr
    Allen E Atchley
    Duke University Medical Center, Durham, NC 27710, USA
    Am Heart J 158:S53-63. 2009

Scientific Experts

  • Kathryn E Flynn
  • SHELBY DERENE REED
  • Steven J Keteyian
  • CHRISTOPHER M O'CONNOR
  • D J Whellan
  • G Michael Felker
  • Stuart D Russell
  • Julius M Gardin
  • Yanhong Li
  • Ann M Swank
  • Kevin A Schulman
  • William E Kraus
  • Jerome L Fleg
  • Gordon Blackburn
  • Marianne Vest
  • Ileana L Pina
  • Emily Gruendler
  • Vera Bittner
  • Brian D Duscha
  • Jessica Staib
  • Phil Peasley
  • Jacqueline Bakos
  • Marcy Sagerian
  • Lori Heiss
  • Douglas Pearce
  • Kim Lyzun
  • Carol Madison
  • Mike Felker
  • Deirdre Nauman
  • John Wertheimer
  • Lucy Piner
  • John Kostis
  • Karen Meyer
  • Debbie Williams
  • Eric S Leifer
  • Mihai Gheorghiade
  • Elizabeth Heck
  • Betsy O'Neal
  • Tehmina Naz
  • Ann Burnette
  • Valerie Johnson
  • Adam Mueller
  • Kelly Dimick
  • Dione Lenz
  • Mark E Dunlap
  • Gregg Fonarow
  • Ludmila Cosio-Lima
  • Eileen Handberg
  • Brian Moore
  • Jana Glotzer
  • Jonathan Howlett
  • Marie Lagasse
  • Lemuel Moye
  • Jennifer Dekerlegand
  • Jonathan K Ehrman
  • Cindy Baumann
  • William Abraham
  • Bertram Pitt
  • Steven Hutchins
  • Denise Herman
  • Susan Moore
  • Theresa Strzelczyk
  • Maria M Lopez
  • Peggy Bennett
  • Leway Chen
  • Michelle Thresher
  • Renee L Bess
  • Annette Contasti
  • Cassondra Vander Ark
  • Michael Zile
  • Joseph O'Bryan
  • Mark Donahue
  • Frank G Yanowitz
  • Lynda H Powell
  • Linda Davidson-Ray
  • Carol Buchter
  • Robert S McKelvie
  • Gerald I Cohen
  • Patty Connolly
  • Dennis McNamara
  • Elena Tokareva
  • Sunday Nkemdiche
  • Cassandra Clancy
  • Susan Leathes
  • Remi Sabatier
  • Anekwe Onwuanyi
  • Gregory Ewald
  • Sharon Boozer
  • Elizabeth Ofili
  • Janice Schrack

Detail Information

Publications19

  1. pmc Associations between Seattle Heart Failure Model scores and health utilities: findings from HF-ACTION
    Yanhong Li
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA
    J Card Fail 19:311-6. 2013
    ..We sought to investigate relationships between SHFM scores and health utility weights, which are necessary to estimate quality-adjusted life-years in cost-effectiveness analyses...
  2. pmc Associations between hemoglobin level, resource use, and medical costs in patients with heart failure: findings from HF-ACTION
    Shelby D Reed
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina 27715, USA
    J Card Fail 18:784-91. 2012
    ..Reports that patients with heart failure and anemia incur greater costs and medical resource use have relied largely on data with limited clinical detail...
  3. pmc Modest increase in peak VO2 is related to better clinical outcomes in chronic heart failure patients: results from heart failure and a controlled trial to investigate outcomes of exercise training
    Ann M Swank
    Exercise Physiology Laboratory University of Louisville, Louisville, KY 40292, USA
    Circ Heart Fail 5:579-85. 2012
    ..The prognostic ability of a single measurement of peak oxygen uptake (VO(2)) is well established in patients with chronic heart failure. The relation between a change in peak VO(2) and clinical outcomes is not well defined...
  4. pmc In-hospital resource use and medical costs in the last year of life by mode of death (from the HF-ACTION randomized controlled trial)
    Shelby D Reed
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA
    Am J Cardiol 110:1150-5. 2012
    ..In conclusion, resource use and associated medical costs in the last year of life differed markedly in patients with HF who experienced SCD and patients who died of other causes...
  5. pmc Relationships between changes in patient-reported health status and functional capacity in outpatients with heart failure
    Kathryn E Flynn
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA
    Am Heart J 163:88-94.e3. 2012
    ..Lack of formal assessments of the relationships between changes in multiple aspects of patient-reported health status and measures of functional capacity over time limits the ability to compare results across studies...
  6. pmc Predicting maximal HR in heart failure patients on β-blockade therapy
    Steven J Keteyian
    Department of Internal Medicine, Henry Ford Hospital, Detroit, MI, USA
    Med Sci Sports Exerc 44:371-6. 2012
    ..This study developed and validated a practical equation to predict maximal HR in patients with heart failure (HF) taking βB therapy...
  7. pmc Economic evaluation of the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) randomized controlled trial: an exercise training study of patients with chronic heart failure
    Shelby D Reed
    Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA
    Circ Cardiovasc Qual Outcomes 3:374-81. 2010
    ..We compared medical resource use and costs incurred by these patients during follow-up...
  8. pmc Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure
    Kathryn E Flynn
    Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA
    Am Heart J 158:S64-71. 2009
    ..We examined associations between patient-reported measures of health-related quality of life and clinical indicators of disease severity in a large, heterogeneous sample of patients with heart failure...
  9. pmc Relationship of age and exercise performance in patients with heart failure: the HF-ACTION study
    Daniel E Forman
    Cardiovascular Division, Brigham and Women s Hospital, and Geriatric Research, Education, and Clinical Center GRECC, VA Boston Healthcare System, Boston, MA, USA
    Am Heart J 158:S6-S15. 2009
    ..Reduced exercise capacity is a chief HF complaint and indicates poorer prognosis, especially among elderly persons, but the mechanisms underlying functional decline in older patients with HF are largely unknown...
  10. pmc Myocardial perfusion, function, and dyssynchrony in patients with heart failure: baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Tr
    Allen E Atchley
    Duke University Medical Center, Durham, NC 27710, USA
    Am Heart J 158:S53-63. 2009
    ..This article addresses the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) gated SPECT imaging (gSPECT) substudy baseline results...
  11. pmc Relationship of Doppler-Echocardiographic left ventricular diastolic function to exercise performance in systolic heart failure: the HF-ACTION study
    Julius M Gardin
    St John Hospital and Medical Center, Detroit, MI Hackensack University Medical Center, Hackensack, NJ 07601, USA
    Am Heart J 158:S45-52. 2009
    ..Although in animal models diastolic dysfunction is associated with worsening exercise capacity and prognosis, information regarding these relationships in patients with established systolic heart failure (HF) is sparse...
  12. pmc N-terminal pro-brain natriuretic peptide and exercise capacity in chronic heart failure: data from the Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study
    G Michael Felker
    Duke Clinical Research Institute, Durham, NC 27705, USA
    Am Heart J 158:S37-44. 2009
    ..To examine the relationship between N-terminal pro-brain natriuretic peptide (NT-proBNP) and exercise capacity in a large contemporary cohort of patients with chronic heart failure...
  13. pmc The relationship between body mass index and cardiopulmonary exercise testing in chronic systolic heart failure
    Tamara B Horwich
    Ronald Reagan UCLA Medical Center, Los Angeles, CA 90095 1679, USA
    Am Heart J 158:S31-6. 2009
    ..The objective of this study was to assess the relationship between BMI and CPX variables, including peak oxygen uptake (VO(2)) at ventilatory threshold, oxygen pulse, and ventilation-carbon dioxide production ratio...
  14. pmc New York Heart Association functional class predicts exercise parameters in the current era
    Stuart D Russell
    Department of Medicine, Johns Hopkins Hospital, Baltimore, MD 21287, USA
    Am Heart J 158:S24-30. 2009
    ..Using baseline data from the HF-ACTION (Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing) study, we examined this relationship...
  15. pmc Baseline differences in the HF-ACTION trial by sex
    Ileana L Pina
    Case Western Reserve University, Cleveland VA Medical Center, Education Department, Wade Park, Cleveland, OH 44106, USA
    Am Heart J 158:S16-23. 2009
    ..Values for a female population from which to draw for this important determination are lacking...
  16. pmc Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial
    Kathryn E Flynn
    Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 27715, USA
    JAMA 301:1451-9. 2009
    ..Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent...
  17. pmc Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial
    CHRISTOPHER M O'CONNOR
    Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA
    JAMA 301:1439-50. 2009
    ..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...
  18. ncbi Heart failure and a controlled trial investigating outcomes of exercise training (HF-ACTION): design and rationale
    David J Whellan
    Department of Medicine, Jefferson Medical College, Philadelphia, PA 19107, USA
    Am Heart J 153:201-11. 2007
    ..Although there are limited clinical data to support the use of exercise training as a means to reduce mortality and morbidity in patients with heart failure, current guidelines state that exercise is beneficial...