Carvedilol in HF With Preserved EF

NCT05553314 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2026-05-19

No results posted yet for this study

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

Interventions

DRUG

Carvedilol

patients randomized to carvedilol group will receive carvedilol-SR.

DRUG

Placebo

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05553314 on ClinicalTrials.gov