Carvedilol in HF With Preserved EF
NCT05553314 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63
Last updated 2026-05-19
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, the investigators will assess the effect of slow-release carvedilol in patients with HFpEF and hypertension. The primary endpoint is the time-averaged proportional changes in NT-proBNP level and GLS change from baseline to month 6.
Conditions
- Heart Failure With Preserved Ejection Fraction
- Beta Blocker
- Myocardial Strain
Interventions
- DRUG
-
Carvedilol
patients randomized to carvedilol group will receive carvedilol-SR.
- DRUG
-
patients randomized to placebo group will receive placebo.
Sponsors & Collaborators
-
Samsung Medical Center
collaborator OTHER -
Wonju Severance Christian Hospital
collaborator OTHER -
Seoul National University Bundang Hospital
lead OTHER
Principal Investigators
-
Dong-Ju Choi, MD, PhD · Seoul National Univeristy Bundang Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-17
- Primary Completion
- 2026-01-08
- Completion
- 2026-01-08
Countries
- South Korea
Study Locations
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