The Initiation Management Predischarge Process for Assessment of Carvedilol Therapy for Heart Failure (IMPACT-HF) Study: design and implications.

The utilization of b-blockers for the treatment of heart failure in the United States is inadequate despite the available data and the current guidelines that support their use. The ongoing Initiation Management Predischarge Process for Assessment of Carvedilol Therapy for Heart Failure (IMPACT-HF) study was designed to determine if initiation of beta-blockade prior to hospital discharge is safe and effective in improving the 60-day use of beta-blockers in patients with heart failure. IMPACT-HF is a community-based, multicenter, open-label trial of 375 heart failure patients randomized to carvedilol initiated before their hospital discharge or to usual care (Heart Failure Society of America guidelines that recommend waiting 2-4 weeks after hospitalization for heart failure before initiating beta-blocker therapy). The entry criteria are nonrestrictive to ensure inclusion of patients reflective of the general heart failure population. The primary endpoint of the study is the number of patients treated with any beta-blocker at 60 days. A concurrently ongoing pilot registry will enroll 550 patients, admitted with exacerbated heart failure, in three phases to collect demographic, clinical, treatment patterns, and outcome data. The trial will test the tolerability of beta-blocker initiation in the hospital setting, develop strategies to improve the use of evidence-based medicine in clinical practice, and explore the patient's course from hospital admission through discharge and up to 60 days. The trial data will determine if in-hospital initiation of beta-blocker therapy is effective at improving the long-term use of pharmacologic agents proven to reduce morbidity and mortality.