HF-ACTION

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The HF-ACTION study is a multicenter, prospective, randomized clinical trial of Usual care plus Exercise Training versus Usual Care for the prevention of all-cause mortality or hospitalization in 3,000 patients with NYHA class II, III, or IV HF and EF < 35%. The UNMH Center will endeavor to enter 30 patisnts. The primary objective is to test the hypothesis that patients with LV systolic dysfunction and NYHA class II-IV symptoms who are given exercise training in addition to usual care will have a 20% lower rate of death and hospitalization over two years than patients who receive usual care alone. Secondary hypotheses are, that the risks associated with exercise training are outweighed by the benefits, that the intervention will significantly improve exercise tolerance, that the intervention will significantly improve the quality of life, and that the intervention will be economically attractive (cost saving or a reasonable value for money). The study population has been chosen to achieve a wide applicability of the results. Basically, any qualifying patient age 18 years or older referred to the trial who meets the inclusion and exclusion criteria will be eliglble. To protect high-risk patients, one exception is the requirement of completing a baseline exercise test without significant exercise-induced arrhythmia or significant new ischemia. The inclusion criteria are a LVEF <35%; NYHA class II, III, or IV heart failure for the previous three months despite a minimum of 6 weeks of treatment; must be on optimal heart failure therapy according to AHA/ACC and HFSA heart failure guidelines, including treatment with ACEI and beta-blocker therapy, or have documented rationale for variation; must be sufficiently stable, by investigator judgment, to begin an exercise program. The exclusion criteria are ain short inability to participate in an exercise training program for the duration of the study, pregnancy or intent to become pregnant, major cardiovascular event in the prior 6 weeks, a cardiovascular procedure or hospitalization for any reason planned in the future, uncorrected valvular disease, HF secondary to congenital heart disease or obstructive cardiomyopathy, pacemakers which prevent attainment of target exercise heart rate. Patients will be selected from the registry of patients in the Heart Failure Clinic. The patients will have an echocardiogram, will do a 6-minute walk test, and a CPX test. The latter will be repeated several times throughout the study. Patients will be randomized to Usual Care only or Usual Care plus exercise Training. Initially, the latter group will have 36 supervised training sessions in the Cardiac Rehabilitation Unit. After this they will be supplied with a treadmill or exercise bicycle which will be supplied free of charge and may be kept after the trial closes. There will be periodic supervised training sessions. Blood will be drawn once and sent to the Duke University Research Institute where it will be kept and used for studies of biomarkers yet to be decided upon. Informed consent will be obtained in accordance with the rules and regulations laid down by the respective institutions and the University of New Mexico's HRRC. Confidentiality will be matintained in the accepted manner. All data will be forwarded to Duke's Clinical research center where the database will be maitained and statistical analyses done.