Gattis Wendy A, O'Connor Christopher M, Gheorghiade Mihai
Department of Medicine, Divisions of Clinical Pharmacology and Cardiology, Duke University Medical Center, Durham, North Carolina, USA.
Rev Cardiovasc Med. 2002;3 Suppl 3:S48-54.
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.
尽管有现有数据和支持使用β受体阻滞剂治疗心力衰竭的现行指南，但在美国，β受体阻滞剂在心力衰竭治疗中的应用并不充分。正在进行的“卡维地洛治疗心力衰竭出院前起始管理评估流程”（IMPACT-HF）研究旨在确定在出院前开始使用β受体阻滞剂对改善心力衰竭患者60天内β受体阻滞剂的使用是否安全有效。IMPACT-HF是一项基于社区的多中心开放标签试验，对375名心力衰竭患者进行随机分组，一组在出院前开始使用卡维地洛，另一组接受常规治疗（美国心力衰竭学会指南建议在心力衰竭住院后等待2至4周再开始β受体阻滞剂治疗）。入选标准没有严格限制，以确保纳入能反映一般心力衰竭人群情况的患者。该研究的主要终点是60天时接受任何β受体阻滞剂治疗的患者数量。一个同时进行的试点登记将分三个阶段纳入550名因心力衰竭加重而入院的患者，以收集人口统计学、临床、治疗模式和结局数据。该试验将测试在医院环境中开始使用β受体阻滞剂的耐受性，制定在临床实践中改善循证医学应用的策略，并探索患者从入院到出院直至60天的病程。试验数据将确定在医院开始β受体阻滞剂治疗对改善已证实可降低发病率和死亡率的药物的长期使用是否有效。
