The restoration of chronotropic competence in heart failure patients with normal ejection fraction (RESET) study: rationale and design.

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 beta-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.