Carvedilol in HF With Reduced Strain and Preserved EF

• Status: Recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborators: Samsung Medical Center; Wonju Severance Christian Hospital
• Treatments: Carvedilol

Criteria

Inclusion Criteria:

• HFpEF > 40%

• GLS < 14%

• NT0proBNP > 400 pg/ml

• no atrial fibrillation

• beta-blocker naive

Exclusion Criteria:

• systolic blood pressure < 110 mmHg, heart rate < 60 beats/min

• contra-indication to beta-blockers