NCT05553314

Carvedilol in HF With Preserved EF

Slow-release CArvedilol in Patients With REduced Strain and Preserved Ejection Fraction Heart Failure (CARE-preserved HF): A Prospective Randomized, Double-Blinded, Multicenter Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Carvedilol	patients randomized to carvedilol group will receive carvedilol-SR.
DRUG	Placebo	patients randomized to placebo group will receive placebo.

Timeline

• Start date: 2021-11-17
• Primary completion: 2024-08-30
• Completion: 2024-12-30
• First posted: 2022-09-23
• Last updated: 2023-11-08

Locations

2 sites across 1 country: South Korea