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Status unknownNCT03948685Updated May 21, 2019

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

A Phase 4 interventional study of Carvedilol SR and Placebo in Heart Failure With Preserved Ejection Fraction, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-05-21.

Sponsored by Yonsei University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Heart Failure With Preserved Ejection Fraction

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Carvedilol SR

    Carvedilol SR 8mg, 16mg, 32mg

    Drug: Carvedilol SR

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugCarvedilol SR

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

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.

    The maximum NT-proBNP value change at baseline.

    Time frame: Baseline

  2. The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.

    The maximum NT-proBNP value change from baseline to 8 weeks.

    Time frame: 8 weeks

  3. 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).

    Time frame: 24 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 8 weeks

  3. 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.

    Time frame: 16 weeks

  4. 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)

    Time frame: 24 weeks

  5. The change in degree of dyspnea using VAS questionnaire

    the change of dyspnea at baseline.

    Time frame: Baseline

  6. The change in degree of dyspnea using VAS questionnaire

    the change of dyspnea after 8 weeks.

    Time frame: 8 weeks

  7. The change in degree of dyspnea using VAS questionnaire

    the change of dyspnea after 16 weeks.

    Time frame: 16 weeks

  8. The change in degree of dyspnea using VAS questionnaire

    the change of dyspnea from baseline to end of trial(24 weeks)

    Time frame: 24 weeks

  9. the change of body weight

    the change of body weight at baseline.

    Time frame: Baseline

  10. the change of body weight

    the change of body weight after 8 weeks.

    Time frame: 8 weeks

  11. the change of body weight

    the change of body weight after 16 weeks.

    Time frame: 16 weeks

  12. the change of body weight

    the change of body weight from baseline to end of trial(24 weeks)

    Time frame: 24 weeks

  13. 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

    Time frame: Baseline

  14. 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

    Time frame: 8 weeks

  15. 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

    Time frame: 16 weeks

  16. 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

    Time frame: 24 weeks

  17. the frequency of hypo/hyperkalemia and worsening kidney function

    the frequency of hypo/hyperkalemia and worsening kidney function during the trial

    Time frame: Baseline

  18. the frequency of hypo/hyperkalemia and worsening kidney function

    the frequency of hypo/hyperkalemia and worsening kidney function during the trial

    Time frame: 8 weeks

  19. the frequency of hypo/hyperkalemia and worsening kidney function

    the frequency of hypo/hyperkalemia and worsening kidney function during the trial

    Time frame: 16 weeks

  20. the frequency of hypo/hyperkalemia and worsening kidney function

    the frequency of hypo/hyperkalemia and worsening kidney function during the trial

    Time frame: 24 weeks

  21. all-cause hospitalization & mortality

    all-cause hospitalization \& mortality during the trial

    Time frame: Baseline

  22. all-cause hospitalization & mortality

    all-cause hospitalization \& mortality during the trial

    Time frame: 8 weeks

  23. all-cause hospitalization & mortality

    all-cause hospitalization \& mortality during the trial

    Time frame: 16 weeks

  24. all-cause hospitalization & mortality

    all-cause hospitalization \& mortality during the trial

    Time frame: 24 weeks

07

Study locations

1 site
  • Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03948685
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
May 14, 2019
Start date
May 2019 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Jan 2021 (estimated)
Last update
May 21, 2019

Study contacts

Seok-Min Kang, MD, Ph.D
Contact
smkang@yuhs.ac
82-2-2228-8450

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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