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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carvedilol SR | Experimental | Carvedilol SR 8mg, 16mg, 32mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carvedilol SR | Drug | blood pressure, heart rate based titrated carvedilol SR for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration. | The maximum NT-proBNP value change at baseline. | 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. | 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). | 24 weeks |
| 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. | the change of surrogate markers(hsTn, hsCRP etc) at baseline. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seok-Min Kang, MD, Ph.D | Contact | 82-2-2228-8450 | smkang@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine | Seoul | 120-752 | South Korea |
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Carvedilol SR vs. Placebo
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| Placebo |
| Drug |
Placebo |
|
| 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. |
| 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. | 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) | 24 weeks |
| The change in degree of dyspnea using VAS questionnaire | the change of dyspnea at baseline. | Baseline |
| The change in degree of dyspnea using VAS questionnaire | the change of dyspnea after 8 weeks. | 8 weeks |
| The change in degree of dyspnea using VAS questionnaire | the change of dyspnea after 16 weeks. | 16 weeks |
| The change in degree of dyspnea using VAS questionnaire | the change of dyspnea from baseline to end of trial(24 weeks) | 24 weeks |
| the change of body weight | the change of body weight at baseline. | Baseline |
| the change of body weight | the change of body weight after 8 weeks. | 8 weeks |
| the change of body weight | the change of body weight after 16 weeks. | 16 weeks |
| the change of body weight | 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 | 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 | 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 | 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 | 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 | the frequency of hypo/hyperkalemia and worsening kidney function during the trial | Baseline |
| the frequency of hypo/hyperkalemia and worsening kidney function | the frequency of hypo/hyperkalemia and worsening kidney function during the trial | 8 weeks |
| the frequency of hypo/hyperkalemia and worsening kidney function | the frequency of hypo/hyperkalemia and worsening kidney function during the trial | 16 weeks |
| the frequency of hypo/hyperkalemia and worsening kidney function | the frequency of hypo/hyperkalemia and worsening kidney function during the trial | 24 weeks |
| all-cause hospitalization & mortality | all-cause hospitalization & mortality during the trial | Baseline |
| all-cause hospitalization & mortality | all-cause hospitalization & mortality during the trial | 8 weeks |
| all-cause hospitalization & mortality | all-cause hospitalization & mortality during the trial | 16 weeks |
| all-cause hospitalization & mortality | all-cause hospitalization & mortality during the trial | 24 weeks |