Division of Cardiology, Department of Medicine, Johns Hopkins Medical Institutions Baltimore, MD, USA.
J Card Fail. 2010 Jan;16(1):17-24. doi: 10.1016/j.cardfail.2009.08.008. Epub 2009 Oct 7.
Heart failure with preserved ejection fraction (HFpEF) is the predominant form of heart failure among the elderly and in women. However, there are few if any evidence-based therapeutic options for HFpEF. The chief complaint of HFpEF is reduced tolerance to physical exertion. Recent data revealed that 1 potential mechanism of exertional intolerance in HFpEF patients is inadequate chronotropic response. Although there is considerable evidence demonstrating the benefits of rate-adaptive pacing (RAP) provided from implantable cardiac devices in patients with an impaired chronotropic response, the effect of RAP in HFpEF is unknown.
The Restoration of Chronotropic CompEtence in Heart Failure PatientS with Normal Ejection FracTion (RESET) study is a prospective, multicenter, double-blind, randomized with stratification, study assessing the effect of RAP on peak oxygen consumption and quality of life. RAP therapy will be evaluated in a crossover paired fashion for each patient within each study stratum. Study strata are based on patient beta-blocker usage at time of enrollment. The study is powered to assess the impact of pacing independently in both strata.
The RESET study seeks to evaluate the potential benefit of RAP in patients with symptomatic mild to moderate HFpEF and chronotropic impairment. Study enrollment began in July 2008.
射血分数保留型心力衰竭（HFpEF）是老年人和女性心力衰竭的主要形式。然而，HFpEF 的治疗方法几乎没有任何基于证据的选择。HFpEF 的主要症状是体力活动耐量降低。最近的数据显示，HFpEF 患者运动不耐受的一个潜在机制是变时性功能不全。尽管有大量证据表明，在变时性功能不全的患者中，植入式心脏设备提供的频率适应性起搏（RAP）具有有益作用，但 RAP 在 HFpEF 中的作用尚不清楚。
射血分数正常心力衰竭患者恢复变时性能力研究（RESET）是一项前瞻性、多中心、双盲、随机、分层研究，旨在评估 RAP 对峰值耗氧量和生活质量的影响。在每个研究分层内，将以交叉配对的方式评估每个患者的 RAP 治疗效果。研究分层基于患者入组时的β受体阻滞剂使用情况。该研究的目的是评估起搏对这两个分层的独立影响。
RESET 研究旨在评估 RAP 在有症状的轻度至中度 HFpEF 和变时性功能不全患者中的潜在益处。研究于 2008 年 7 月开始招募患者。
