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)
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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
研究组 & 干预措施
Carvedilol SR
Carvedilol SR 8mg, 16mg, 32mg
干预措施: Carvedilol SR (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The Maximum NT-proBNP value change after Drug(Carvedilol SR or Placebo) administration.
时间窗: 24 weeks
The maximum NT-proBNP value change from baseline to End of trial(24weeks).
次要结局
- The change in degree of dyspnea using VAS questionnaire(24 weeks)
- all-cause hospitalization & mortality(24 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.(24 weeks)
- the frequency of hypo/hyperkalemia and worsening kidney function(24 weeks)
- the change of body weight(24 weeks)
- the frequency of symptomatic hypotension, symptomatic bradycardia and AV block above 2nd degree(24 weeks)