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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

Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date May 21, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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.
  • 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.
  • 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.
  • 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)
  • The change in degree of dyspnea using VAS questionnaire [ Time Frame: Baseline ]
    the change of dyspnea at baseline.
  • The change in degree of dyspnea using VAS questionnaire [ Time Frame: 8 weeks ]
    the change of dyspnea after 8 weeks.
  • The change in degree of dyspnea using VAS questionnaire [ Time Frame: 16 weeks ]
    the change of dyspnea after 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)
  • the change of body weight [ Time Frame: Baseline ]
    the change of body weight at baseline.
  • the change of body weight [ Time Frame: 8 weeks ]
    the change of body weight after 8 weeks.
  • the change of body weight [ Time Frame: 16 weeks ]
    the change of body weight after 16 weeks.
  • the change of body weight [ Time Frame: 24 weeks ]
    the change of body weight from baseline to end of trial(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
  • 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
  • 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
  • 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
  • the frequency of hypo/hyperkalemia and worsening kidney function [ Time Frame: Baseline ]
    the frequency of hypo/hyperkalemia and worsening kidney function during the trial
  • 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
  • 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
  • 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
  • all-cause hospitalization & mortality [ Time Frame: Baseline ]
    all-cause hospitalization & mortality during the trial
  • all-cause hospitalization & mortality [ Time Frame: 8 weeks ]
    all-cause hospitalization & mortality during the trial
  • all-cause hospitalization & mortality [ Time Frame: 16 weeks ]
    all-cause hospitalization & mortality during the trial
  • all-cause hospitalization & mortality [ Time Frame: 24 weeks ]
    all-cause hospitalization & mortality during the trial
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Carvedilol SR Study for Biomarkers From Blood and Urine and Safety of in Patients With Heart Failure With Preserved Ejection Fraction
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Carvedilol SR vs. Placebo
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure With Preserved Ejection Fraction
Intervention  ICMJE
  • Drug: Carvedilol SR
    blood pressure, heart rate based titrated carvedilol SR for 24 weeks
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Carvedilol SR
    Carvedilol SR 8mg, 16mg, 32mg
    Intervention: Drug: Carvedilol SR
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seok-Min Kang, MD, Ph.D 82-2-2228-8450 smkang@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03948685
Other Study ID Numbers  ICMJE 4-2018-1061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP