Carvedilol in HF With Reduced Strain and Preserved EF
Status:
Recruiting
Trial end date:
2024-08-30
Target enrollment:
Participant gender:
Summary
Beta-blockers improve clinical outcomes in heart failure and reduced ejection fraction
(HFrEF); but not in those with preserved EF. Global longitudinal strain (GLS) is a prognostic
factor independent of left ventricular ejection fraction (LVEF). In a retrospective with 1969
patients with HF and LVEF of ≥40%, beta-blocker was associated with improved survival in
those with low GLS (GLS <14%), but not in those with GLS ≥14%. In this prospective,
randomized clinical study, we will assess the effect of carvedilol in patients with HF and EF
> 40% and GLS < 14% and N-terminal pro-B-type natriuretic peptide (NT-proBNP) > 400 pg/mL.
The primary endpoint is the time-averaged proportional changes in NT-proBNP level from
baseline through month 3. The secondary endpoints include the change in NT -proBNP at month 3
and month 6.
Phase:
Phase 4
Details
Lead Sponsor:
Seoul National University Bundang Hospital
Collaborators:
Samsung Medical Center Wonju Severance Christian Hospital