Heart failure (HF) is one of the few cardiovascular conditions that is increasing in prevalence. It is a chronic illness that progresses to increasing functional decline, repeated hospitalizations, and placement in long-term care, all of which result in considerable health care expenditures. Progression can be slowed by drug therapy and lifestyle modifications, but non-adherence to these treatment recommendations has been high, approaching 90% in some populations. Innovative interventions that improve adherence and slow progression of HF are needed. The Heart Failure Adherence and Retention Trial (HART) (ROl HL65547) is single-site, multiple hospital behavioral randomized clinical aimed at? Determining the efficacy of a 1-year, group-based self-management intervention, compared to an attention control, on the 2 primary endpoints of death/HF hospitalizations and death/all-cause hospitalizations. Secondary endpoints include progression of HF, quality of life, health care costs, adherence, and psychosocial stress. HART successfully met its recruitment goal of 902 patients with mild to moderate HF. The cohort features 47% women, 39% minority patients, and 33% patients with diastolic dysfunction. It is more representative of clinical practice than most cohorts in clinical trials. Excellent quality control procedures have been put in place for the collection of data and delivery of the interventions. This is a request for a 1.5-year competitive continuation of HART. The reasons for this request are (1) recruitment took 1 year longer than expected thus cutting short the follow-up period by 1 year and jeopardizing the power of the trial; and (2) the NIH requirement for data archiving and dissemination activities was put in place after the start of HART and thus no resources are available for these activities. The independent HART Data and Safety Monitoring Board has been unblinded to outcome data for the past 1.5 years and has urged HART to make this request for a continuation. The questions posed by HART are as important now as they were judged to be by the study section in 2001. This request will make it possible to answer these questions conclusively.
