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

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ClinicalTrials.gov Identifier: NCT03948685
Recruitment Status : Not yet recruiting
First Posted : May 14, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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

Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction Drug: Carvedilol SR Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Carvedilol SR vs. Placebo
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Carvedilol

Arm Intervention/treatment
Experimental: Carvedilol SR
Carvedilol SR 8mg, 16mg, 32mg
Drug: Carvedilol SR
blood pressure, heart rate based titrated carvedilol SR for 24 weeks

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration. [ Time Frame: Baseline ]
    The maximum NT-proBNP value change at baseline.

  2. 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.

  3. 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).


Secondary Outcome Measures :
  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. [ Time Frame: Baseline ]
    the change of surrogate markers(hsTn, hsCRP etc) at 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. [ Time Frame: 8 weeks ]
    the change of surrogate markers(hsTn, hsCRP etc) after 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. [ Time Frame: 16 weeks ]
    the change of surrogate markers(hsTn, hsCRP etc) after 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. [ Time Frame: 24 weeks ]
    the change of surrogate markers(hsTn, hsCRP etc) from baseline to end of trial(24 weeks)

  5. The change in degree of dyspnea using VAS questionnaire [ Time Frame: Baseline ]
    the change of dyspnea at baseline.

  6. The change in degree of dyspnea using VAS questionnaire [ Time Frame: 8 weeks ]
    the change of dyspnea after 8 weeks.

  7. The change in degree of dyspnea using VAS questionnaire [ Time Frame: 16 weeks ]
    the change of dyspnea after 16 weeks.

  8. 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)

  9. the change of body weight [ Time Frame: Baseline ]
    the change of body weight at baseline.

  10. the change of body weight [ Time Frame: 8 weeks ]
    the change of body weight after 8 weeks.

  11. the change of body weight [ Time Frame: 16 weeks ]
    the change of body weight after 16 weeks.

  12. the change of body weight [ Time Frame: 24 weeks ]
    the change of body weight from baseline to end of trial(24 weeks)

  13. 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

  14. 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

  15. 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. 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

  17. the frequency of hypo/hyperkalemia and worsening kidney function [ Time Frame: Baseline ]
    the frequency of hypo/hyperkalemia and worsening kidney function during the trial

  18. 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

  19. 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

  20. 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

  21. all-cause hospitalization & mortality [ Time Frame: Baseline ]
    all-cause hospitalization & mortality during the trial

  22. all-cause hospitalization & mortality [ Time Frame: 8 weeks ]
    all-cause hospitalization & mortality during the trial

  23. all-cause hospitalization & mortality [ Time Frame: 16 weeks ]
    all-cause hospitalization & mortality during the trial

  24. all-cause hospitalization & mortality [ Time Frame: 24 weeks ]
    all-cause hospitalization & mortality during the trial



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948685


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

Locations
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Korea, Republic of
Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03948685    
Other Study ID Numbers: 4-2018-1061
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists