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

NCT ID: NCT03948685

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2021-01-31

Brief 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

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carvedilol SR

Carvedilol SR 8mg, 16mg, 32mg

Group Type: EXPERIMENTAL

Carvedilol SR

Intervention Type: DRUG

blood pressure, heart rate based titrated carvedilol SR for 24 weeks

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

Carvedilol SR

blood pressure, heart rate based titrated carvedilol SR for 24 weeks

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Countries

South Korea

Central Contacts

Seok-Min Kang, MD, Ph.D

Role: CONTACT

smkang@yuhs.ac

82-2-2228-8450

Other Identifiers

4-2018-1061

Identifier Type: -

Identifier Source: org_study_id