drugset / Trial / NCT03948685

Carvedilol SR Study for Biomarkers From Blood and Urine and Safety of in Patients With Heart Failure With Preserved Ejection Fraction

NCT03948685

Phase 4 Unknown 300 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

Summary

Beta blockers have been used to reduce the mortality and heart failure rehospitalization in heart failure with reduced ejection fraction (HFrEF) patients in addition to ACEI/ARB, MRA, ivabradine and ARNI. However, the effective and safe medical therapy is not well established in heart failure with preserved ejection fraction (HFpEF) yet. Recent meta-analysis showed that beta blockers may also be beneficial for reducing the mortality and heart failure rehospitalization in HFpEF like HFrEF. However, the clinical effect and safety of carvedilol have been largely unknown in HFpEF. Therefore, CAYMUS HFpEF is the exploratory study to assess the change of surrogate markers (NTproBNP, hsTn) when treated with carvedilol SR vs. placebo in HFpEF patients

Timeline

Start
2019-05
Primary completion
2020-12
Completion
2021-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Carvedilol Other / unclassified 8 mg
Subject Carvedilol Other / unclassified 16 mg
Subject Carvedilol Other / unclassified 32 mg