Carvedilol SR Study for Biomarkers From Blood and Urine and Safety of in Patients With Heart Failure With Preserved Ejection Fraction
1 other identifier
interventional
300
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
May 3, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedMay 21, 2019
May 1, 2019
1.6 years
May 3, 2019
May 19, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
The maximum NT-proBNP value change at baseline.
Baseline
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
The maximum NT-proBNP value change from baseline to 8 weeks.
8 weeks
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
The maximum NT-proBNP value change from baseline to End of trial(24weeks).
24 weeks
Secondary Outcomes (24)
The changes of maximum surrogate markers values(hsTn, hsCRP, sST2, Galectine-3, IGFBP7, Neprilysin, D-dimer, MMP-2, Cystatin C, NAG, NGAL, KIM-1, BUN, Creatinine, Chloride, Na, K, PICP and spondin-1) after Drug(Carvedilol SR or Placebo) administration.
Baseline
The changes of maximum surrogate markers values(hsTn, hsCRP, sST2, Galectine-3, IGFBP7, Neprilysin, D-dimer, MMP-2, Cystatin C, NAG, NGAL, KIM-1, BUN, Creatinine, Chloride, Na, K, PICP and spondin-1) after Drug(Carvedilol SR or Placebo) administration.
8 weeks
The changes of maximum surrogate markers values(hsTn, hsCRP, sST2, Galectine-3, IGFBP7, Neprilysin, D-dimer, MMP-2, Cystatin C, NAG, NGAL, KIM-1, BUN, Creatinine, Chloride, Na, K, PICP and spondin-1) after Drug(Carvedilol SR or Placebo) administration.
16 weeks
The changes of maximum surrogate markers values(hsTn, hsCRP, sST2, Galectine-3, IGFBP7, Neprilysin, D-dimer, MMP-2, Cystatin C, NAG, NGAL, KIM-1, BUN, Creatinine, Chloride, Na, K, PICP and spondin-1) after Drug(Carvedilol SR or Placebo) administration.
24 weeks
The change in degree of dyspnea using VAS questionnaire
Baseline
- +19 more secondary outcomes
Study Arms (2)
Carvedilol SR
EXPERIMENTALCarvedilol SR 8mg, 16mg, 32mg
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Provision of informed consent prior to any study specific procedure
- Male or female, aged ≥ 19 years
- 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
- Structural heart disease within 6 months prior to Visit 1 using echocardiagraphy
You may not qualify if:
- 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
- Contraindication to beta blocker
- Heart transplant recipient or listed for heart transplant
- Hospitalization plan for PCI, coronary artery bypass graft surgery, other cardiac invasive interventions (e.g. catheter ablation, pacemaker, CRT, ICD implantation)
- Acute decompensated HF (Heart Failure)
- Symptomatic hypotension or systolic blood pressure \< 100 mmHg)
- Patients with CrCl \< 30 ml/min using creatinine-based CKD-EPI equations
- Elevated liver enzymes (3 times over upper reference limit) or liver cirrhosis
- Symptomatic bradycardia or heart rate \< 60/min
- Allergy, adverse drug reaction, hypersensitivity to carvedilol
- Life expectancy \< 6 months (e.g. metastatic malignancy)
- Pregnancy, or women of childbearing age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2019
First Posted
May 14, 2019
Study Start
May 1, 2019
Primary Completion
December 1, 2020
Study Completion
January 1, 2021
Last Updated
May 21, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share