Rationale and design of the β‐blocker in heart failure with normal left ventricular ejection fraction (β‐PRESERVE) study

Abstract

Chronic heart failure with normal left ventricular ejection fraction (HFNEF) is not only common, but also carries a high risk of substantial morbidity and mortality. However, few studies have been conducted in this population and no proven treatment is available. Although beta-blockers are evidence-based first-line therapy in systolic heart failure, they have not been well studied in HFNEF. This study is a multicentre, prospective, randomized, open-label, blinded endpoint (PROBE) trial. A total of 1200 patients will be randomized to either beta-blocker (metoprolol succinate) or control (n = 600 per group). The primary endpoint is a composite of hospitalization for heart failure and cardiovascular death. The secondary endpoints include cardiovascular death, heart failure mortality or hospitalization, all-cause mortality, change in New York Heart Association class, change in left ventricular ejection fraction, increase in NT-proBNP (by > or = 50% of the value at randomization), beta-blocker tolerance, and premature termination of beta-blocker therapy due to adverse events. The follow-up period is a minimum of 2 years. This study will provide important evidence, for the first time to our knowledge, of the long-term efficacy of beta-blocker therapy in the management of HFNEF.