NCT03209180

Immediate Release Versus Slow Release Carvedilol in Heart Failure

Assessment of Clinical Effect and Treatment Quality of Rapid Release Carvedilol Versus SLOW Release Carvedilol-SR in HEART FAILURE Patient (SLOW-HF): A Prospective Randomized, Open-label, Multicenter Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Assessment of clinical effect and treatment quality of immediate release carvedilol (IR) versus slow release carvedilol (SR) in patients with HFrEF

Detailed description

The SLOW-HF trial is a phase 4, randomized, open label, multicenter study to evaluate the therapeutic efficacy of carvedilol-SR compared to carvedilol-IR in patients with heart failure with reduced ejection fraction. Patients with stable HFrEF will be randomly assigned (1:1) to carvedilol SR group (160 patients) and carvedilol IR group (160 patients). After randomization, patients will be followed for 6 months. The primary endpoint is the change in NT-proBNP level from baseline to the study end. The secondary endpoints include the frequency of NT-proBNP increment \>10% from baseline, composite of all-cause mortality and readmission, mortality rate, readmission rate, changes in blood pressure, quality of life, and drug compliance.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DRUG	CarVeDilol-SR (Slow Release)	patients will receive slow-release carvedilol (SR) once daily
DRUG	Carvedilol IR (Immediate Release)	patients will receive immediate release carvedilol (IR) twice daily

Timeline

• Start date: 2016-10-27
• Primary completion: 2018-06-25
• Completion: 2018-12-31
• First posted: 2017-07-06
• Last updated: 2017-07-06

Locations

13 sites across 1 country: South Korea