The Restoration of Chronotropic CompEtence in Heart Failure PatientS with Normal Ejection FracTion (RESET) Study: Rationale and Design
Received 15 June 2009; received in revised form 12 August 2009; accepted 17 August 2009. published online 08 October 2009.
Abstract
Background
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.
Methods and Results
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 β-blocker usage at time of enrollment. The study is powered to assess the impact of pacing independently in both strata.
Conclusions
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.
Reprint requests: David A. Kass, MD, Ross 858, Division of Cardiology, Johns Hopkins University Medical Institutions, 720 Rutland Avenue, Baltimore, MD 21205. Tel: (410) 955-7153; Fax: (410) 502-2558.
Drs. Kass and Kitzman have received honoraria as consultants from Boston Scientific CRM. Dr. Alvarez is an employee of Boston Scientific CRM.
ABSTRACT