Zhou 2010.
Trial name or title | b‐PRESERVE |
Methods | Study design: "multicentre, prospective, randomized, open‐label, blinded endpoint trial" |
Participants | "A total of 1200 patients will be randomized to either b‐blocker (metoprolol succinate) or control (n = 600 per group)." "The most essential criteria for HFNEF in this trial are: heart failure symptoms, elevated NT‐proBNP 1500 pg/mL, and LVEF 50%. In addition, age .40 years and a recent hospitalization for heart failure, but not within 3 months prior to enrolment, are required." |
Interventions | "The follow‐up period is a minimum of 2 years." |
Outcomes | "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 50% of the value at randomization), b‐blocker tolerance, and premature termination of b‐blocker therapy due to adverse events" |
Starting date | not reported |
Contact information | Email: ge.junbo@zs‐hospital.sh.cn or jbge@zs‐hospital.sh.cn |
Notes | Could not find the entry in the Chinese Clinical Trial Register with ID ChiCTR‐TNC‐00000144. Contacted investigators to clarify status of study. No response. |
ACEI: angiotensin‐converting‐enzyme inhibitor
ARB: angiotensin II receptor blockers
CMR: cardiac magnetic resonance
ECV: extra‐cellular volume
HTN: hypertension
KCCQ: Kansas City Cardiomyopathy Questionnaire
LVEF: left ventricular ejection fraction
NYHA: New York Heart Association Classification of heart failure
QoL: quality of life
RCT: randomised controlled trial