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David J. Whellan, MD, MHS Jefferson Medical College, Philadelphia, PA Christopher M. O’Connor, MD

O’Connor - 3318. Efficacy and Safety of Exercise Training as a Treatment Modality in Patients With Chronic Heart Failure: Results of A Randomized C ontrolled T rial I nvestigating O utcomes of Exercise Trai N ing (HF-ACTION). David J. Whellan, MD, MHS

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David J. Whellan, MD, MHS Jefferson Medical College, Philadelphia, PA Christopher M. O’Connor, MD

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  1. O’Connor - 3318 Efficacy and Safety of Exercise Training as a Treatment Modality in Patients With Chronic Heart Failure: Results of A Randomized Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) David J. Whellan, MD, MHS Jefferson Medical College, Philadelphia, PA Christopher M. O’Connor, MD Duke University Medical Center, Durham, NC on behalf of the HF-ACTION Steering Committee, Investigators, and Coordinators Funded by NHLBI Ancillary studies funded by GE Healthcare and Roche Diagnostics Financial Disclosures: Research Support: GE Healthcare, Roche Diagnostics

  2. Background • In past studies, exercise training has • Increased exercise capacity • Improved quality of life • Improved biomarkers • Possibly improved survival • Limitations • Relatively small • Majority single-center • Underpowered to evaluate mortality and morbidity • Lack of adequate control groups • Limited safety data

  3. HF-ACTION Outcomes • All-cause mortality + hospitalization: Primary • CV mortality + CV hospitalization • CV mortality + HF hospitalization • Mortality • Safety • Physiologic endpoints: CPX and 6MW • QOL • Cost

  4. Study Design Chronic heart failure, NYHA Class II-IV, LVEF ≤ 35%, optimal medical therapy, and capable of exercising Pre-randomization CPX and ECHO Randomization 1:1 (Stratified by center and HF etiology) Usual Care Exercise Training Optimized medical treatment Patient education Phone calls Recommendation: Moderate intensity activity 30 minutes/day Optimized medical treatment Patient education Phone calls Supervised training Home training

  5. Time to All-Cause Mortality or All-Cause Hospitalization HR 0.93 (95% CI: 0.84, 1.02), P=0.13

  6. Summary of Major Outcomes

  7. Limitations • Adherence in exercise training group and physical activity by the usual care group may have diminished the identified benefit of exercise training • Blinding of subjects and research personnel not possible • Core labs blinded • Clinical Endpoint Committee blinded • Home exercise adherence data are difficult to collect and to precisely quantify

  8. Conclusions • The HF- ACTION Trial is the largest and most comprehensive study of exercise training in patients with heart failure. • Based on the protocol-specified primary analysis, exercise training produced a modest, non-significant decrease in the primary endpoint (all-cause mortality or all-cause hospitalization) and key secondary clinical endpoints. • In secondary analyses, with adjustment for the most significant, objectively-determined prognostic factors, the adjusted treatment effect was statistically significant for the primary endpoint and for the secondary endpoint of CV mortality or HF hospitalization. • The HF-ACTION study results support a structured exercise training program for patients with reduced LV function and HF symptoms in addition to evidence-based therapy.

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