Overview

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

Status:
Unknown status

Trial end date:
2021-01-01

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yonsei University

Treatments:

Carvedilol

Criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedure

2. Male or female, aged ≥ 19 years

3. Patients with chronic HF (Chronic Heart Failure) NYHA (New York Heart Association
classification) class II-IV and preserved EF (Ejection Fraction)(LVEF (Left
Ventricular Ejection Fraction) > 40 %) and elevated NT-proBNP (N-terminal of the
prohormone brain natriuretic peptide) > 200 pg/ml for patients without AF, OR > 600
pg/ml for patients with AF, analysed at the Central laboratory at Visit 1

4. Structural heart disease within 6 months prior to Visit 1 using echocardiagraphy

Exclusion Criteria:

1. Myocardial infarction, coronary artery bypass graft surgery or other major
cardiovascular surgery, stroke or TIA (Transient Ischaemic Attack) in past 90 days
prior to Visit 1

2. Contraindication to beta blocker

3. Heart transplant recipient or listed for heart transplant

4. Hospitalization plan for PCI, coronary artery bypass graft surgery, other cardiac
invasive interventions (e.g. catheter ablation, pacemaker, CRT, ICD implantation)

5. Acute decompensated HF (Heart Failure)

6. Symptomatic hypotension or systolic blood pressure < 100 mmHg)

7. Patients with CrCl < 30 ml/min using creatinine-based CKD-EPI equations

8. Elevated liver enzymes (3 times over upper reference limit) or liver cirrhosis

9. Symptomatic bradycardia or heart rate < 60/min

10. Allergy, adverse drug reaction, hypersensitivity to carvedilol

11. Life expectancy < 6 months (e.g. metastatic malignancy)

12. Pregnancy, or women of childbearing age