Rationale and design of the beta-blocker in heart failure with normal left ventricular ejection fraction (beta-PRESERVE) study.
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
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.
Zhou
Jingmin
J
Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Disease, Shanghai, China.
Shi
Haiming
H
Zhang
Jian
J
Lu
Yongxin
Y
Fu
Michael
M
Ge
Junbo
J
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000704:Analysis of Variance; D000959:Antihypertensive Agents / Q000627:therapeutic use*; D023381:Endpoint Determination; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D008297:Male; D008790:Metoprolol / Q000627:therapeutic use; D015999:Multivariate Analysis; D012107:Research Design; D016037:Single-Blind Method; D016277:Ventricular Function, Left
D000319:Adrenergic beta-Antagonists; D000959:Antihypertensive Agents; D008790:Metoprolol