1. Rationale and design of the β-blocker in heart failure with normal left ventricular ejection fraction (β-PRESERVE) study
- Author
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Jingmin, Zhou, Haiming, Shi, Jian, Zhang, Yongxin, Lu, Michael, Fu, Junbo, Ge, and Zhimin, Du
- Subjects
Adult ,Male ,medicine.medical_specialty ,Endpoint Determination ,medicine.drug_class ,Adrenergic beta-Antagonists ,Population ,Ventricular Function, Left ,law.invention ,Randomized controlled trial ,law ,Internal medicine ,Humans ,Medicine ,Single-Blind Method ,Beta (finance) ,education ,Beta blocker ,Antihypertensive Agents ,Heart Failure ,Analysis of Variance ,education.field_of_study ,Ejection fraction ,Ventricular function ,business.industry ,medicine.disease ,Multicenter study ,Research Design ,Heart failure ,Multivariate Analysis ,Cardiology ,Female ,Cardiology and Cardiovascular Medicine ,business ,Metoprolol - 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 (byor = 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.
- Published
- 2010
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