Heart Failure With Preserved Ejection FractionPhase 4NCT03948685
Carvedilol SR Study for Biomarkers From Blood and Urine and Safety of in Patients With Heart Failure With Preserved Ejection Fraction
A Phase 4 study testing Carvedilol SR in people with Heart Failure With Preserved Ejection Fraction, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Carvedilol SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2019to Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752
About this study
Official title: 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
- Being tested
- Carvedilol SR, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carvedilol SRDrug
blood pressure, heart rate based titrated carvedilol SR for 24 weeks
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol SR | Experimental | Carvedilol SR 8mg, 16mg, 32mg Receives: Drug: Carvedilol SR |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
The maximum NT-proBNP value change at baseline.
Measured: 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.
Measured: 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).
Measured: 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.
the change of surrogate markers(hsTn, hsCRP etc) at baseline.
Measured: 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.
the change of surrogate markers(hsTn, hsCRP etc) after 8 weeks.
Measured: 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.
the change of surrogate markers(hsTn, hsCRP etc) after 16 weeks.
Measured: 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.
the change of surrogate markers(hsTn, hsCRP etc) from baseline to end of trial(24 weeks)
Measured: 24 weeks
The change in degree of dyspnea using VAS questionnaire
the change of dyspnea at baseline.
Measured: Baseline
The change in degree of dyspnea using VAS questionnaire
the change of dyspnea after 8 weeks.
Measured: 8 weeks
The change in degree of dyspnea using VAS questionnaire
the change of dyspnea after 16 weeks.
Measured: 16 weeks
The change in degree of dyspnea using VAS questionnaire
the change of dyspnea from baseline to end of trial(24 weeks)
Measured: 24 weeks
the change of body weight
the change of body weight at baseline.
Measured: Baseline
the change of body weight
the change of body weight after 8 weeks.
Measured: 8 weeks
the change of body weight
the change of body weight after 16 weeks.
Measured: 16 weeks
the change of body weight
the change of body weight from baseline to end of trial(24 weeks)
Measured: 24 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree during the tiral
Measured: Baseline
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree during the tiral
Measured: 8 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree during the tiral
Measured: 16 weeks
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree
the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree during the tiral
Measured: 24 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
the frequency of hypo/hyperkalemia and worsening kidney function during the trial
Measured: Baseline
the frequency of hypo/hyperkalemia and worsening kidney function
the frequency of hypo/hyperkalemia and worsening kidney function during the trial
Measured: 8 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
the frequency of hypo/hyperkalemia and worsening kidney function during the trial
Measured: 16 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
the frequency of hypo/hyperkalemia and worsening kidney function during the trial
Measured: 24 weeks
all-cause hospitalization & mortality
all-cause hospitalization \& mortality during the trial
Measured: Baseline
all-cause hospitalization & mortality
all-cause hospitalization \& mortality during the trial
Measured: 8 weeks
all-cause hospitalization & mortality
all-cause hospitalization \& mortality during the trial
Measured: 16 weeks
all-cause hospitalization & mortality
all-cause hospitalization \& mortality during the trial
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study startMay 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Carvedilol SR vs. Placebo
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948685
- Sponsor's protocol ID
- 4-2018-1061
- Status last verified
- May 2019
- First submitted
- 3 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03948685
- Acronym / sponsor ID
- 4-2018-1061
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 14 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Carvedilol SR vs. Placebo
| Arm | Type | Receives |
|---|---|---|
| Carvedilol SR | Experimental | Drug: Carvedilol SRCarvedilol SR 8mg, 16mg, 32mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carvedilol SRblood pressure, heart rate based titrated carvedilol SR for 24 weeks | Drug | Carvedilol SR |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
Time frame: Baseline
The maximum NT-proBNP value change at 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.
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 secondary outcomes
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 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 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 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 in degree of dyspnea using VAS questionnaire
Time frame: Baseline
The change in degree of dyspnea using VAS questionnaire
Time frame: 8 weeks
The change in degree of dyspnea using VAS questionnaire
Time frame: 16 weeks
The change in degree of dyspnea using VAS questionnaire
Time frame: 24 weeks
the change of body weight
Time frame: Baseline
the change of body weight
Time frame: 8 weeks
the change of body weight
Time frame: 16 weeks
the change of body weight
Time frame: 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
Time frame: 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
Time frame: 24 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
Time frame: Baseline
the frequency of hypo/hyperkalemia and worsening kidney function
Time frame: 8 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
Time frame: 16 weeks
the frequency of hypo/hyperkalemia and worsening kidney function
Time frame: 24 weeks
all-cause hospitalization & mortality
Time frame: Baseline
all-cause hospitalization & mortality
Time frame: 8 weeks
all-cause hospitalization & mortality
Time frame: 16 weeks
all-cause hospitalization & mortality
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Carvedilol SR in people with Heart Failure With Preserved Ejection Fraction, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seok-Min Kang, MD, Ph.D (82-2-2228-8450, smkang@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration. (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.