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

May 19, 2019 updated by: Yonsei University

Carvedilol SR Study for Biomarkers From Blood and Urine and Safety of in Patients With Heart Failure With Preserved Ejection Fraction : a Prospective, Randomized, Double Blind, Placebo-controlled, Multicenter, Pilot Trial (CAYMUS-HFpEF)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Seok-Min Kang, MD, Ph.D
  • Phone Number: 82-2-2228-8450
  • Email: smkang@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo
EXPERIMENTAL: Carvedilol SR
Carvedilol SR 8mg, 16mg, 32mg
Drug: Carvedilol SR
blood pressure, heart rate based titrated carvedilol SR for 24 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
Time Frame: Baseline
The maximum NT-proBNP value change at baseline.
Baseline
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
Time Frame: 8 weeks
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.
Time Frame: 24 weeks
The maximum NT-proBNP value change from baseline to End of trial(24weeks).
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline
the change of surrogate markers(hsTn, hsCRP etc) at baseline.
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.
Time Frame: 8 weeks
the change of surrogate markers(hsTn, hsCRP etc) after 8 weeks.
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.
Time Frame: 16 weeks
the change of surrogate markers(hsTn, hsCRP etc) after 16 weeks.
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.
Time Frame: 24 weeks
the change of surrogate markers(hsTn, hsCRP etc) from baseline to end of trial(24 weeks)
24 weeks
The change in degree of dyspnea using VAS questionnaire
Time Frame: Baseline
the change of dyspnea at baseline.
Baseline
The change in degree of dyspnea using VAS questionnaire
Time Frame: 8 weeks
the change of dyspnea after 8 weeks.
8 weeks
The change in degree of dyspnea using VAS questionnaire
Time Frame: 16 weeks
the change of dyspnea after 16 weeks.
16 weeks
The change in degree of dyspnea using VAS questionnaire
Time Frame: 24 weeks
the change of dyspnea from baseline to end of trial(24 weeks)
24 weeks
the change of body weight
Time Frame: Baseline
the change of body weight at baseline.
Baseline
the change of body weight
Time Frame: 8 weeks
the change of body weight after 8 weeks.
8 weeks
the change of body weight
Time Frame: 16 weeks
the change of body weight after 16 weeks.
16 weeks
the change of body weight
Time Frame: 24 weeks
the change of body weight from baseline to end of trial(24 weeks)
24 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree
Time Frame: Baseline
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree during the tiral
Baseline
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree
Time Frame: 8 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree during the tiral
8 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree
Time Frame: 16 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree during the tiral
16 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree
Time Frame: 24 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree during the tiral
24 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
Time Frame: Baseline
the frequency of hypo/hyperkalemia and worsening kidney function during the trial
Baseline
the frequency of hypo/hyperkalemia and worsening kidney function
Time Frame: 8 weeks
the frequency of hypo/hyperkalemia and worsening kidney function during the trial
8 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
Time Frame: 16 weeks
the frequency of hypo/hyperkalemia and worsening kidney function during the trial
16 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
Time Frame: 24 weeks
the frequency of hypo/hyperkalemia and worsening kidney function during the trial
24 weeks
all-cause hospitalization & mortality
Time Frame: Baseline
all-cause hospitalization & mortality during the trial
Baseline
all-cause hospitalization & mortality
Time Frame: 8 weeks
all-cause hospitalization & mortality during the trial
8 weeks
all-cause hospitalization & mortality
Time Frame: 16 weeks
all-cause hospitalization & mortality during the trial
16 weeks
all-cause hospitalization & mortality
Time Frame: 24 weeks
all-cause hospitalization & mortality during the trial
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4-2018-1061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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