A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects With Chronic Heart Failure (CARDINAL-HF)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at Week 4.
研究概览
简要总结
This is a study evaluating the effectiveness of CRD-740 in patients with either Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Preserved Ejection Fraction (HFpEF) after 12 weeks of treatment. The primary objective in Part A is to assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in HFrEF.
Part B of the study was not conducted in favor of redesigned new studies.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or Females ≥18 years of age, at screening.
- •Diagnosis of clinical heart failure syndrome, New York Heart Association functional class II - III for at least 6 months prior to screening
- •For Part A:
- •Ejection Fraction ≤40% by echocardiography at screening.
- •NT-proBNP level ≥600 pg/ml at screening. Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥1000 pg/mL at screening.
- •Stable doses of guideline-directed heart failure therapy for a minimum of 4 weeks prior to screening that has been individually optimized according to standard practice guidelines and no addition of guideline-directed heart failure therapy within 3 months of screening.
排除标准
- •Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening.
- •Subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study.
- •Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening.
- •Subjects with clinical suspicion of infiltrative cardiomyopathy (e.g., amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.
- •Prior or planned orthotopic heart transplantation.
- •Presence of or plan for mechanical circulatory support.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Placebo
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.
干预措施: Placebo (Drug)
CRD-740
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks.
干预措施: CRD-740 (Drug)
结局指标
主要结局
Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at Week 4.
时间窗: Baseline to Week 4
Efficacy: To assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in subjects with CHFrEF.
次要结局
未报告次要终点