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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Heart Failure With Preserved Ejection Fraction

Treatments: Drug: Carvedilol SR; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03948685

4-2018-1061

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Carvedilol SR

Experimental group

Description:

Carvedilol SR 8mg, 16mg, 32mg

Treatment:

Drug: Carvedilol SR

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo