NCT06369298进行中（未招募）2 期
A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of JK07 in Adults With Chronic Heart Failure (RENEU-HF)
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 282
- 试验地点
- 124
- 主要终点
- Safety - Cohort 2
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled, multiple dose study to assess the safety, tolerability, and efficacy of JK07 in participants aged 18-85 with heart failure.
There will be 2 cohorts in this study:
Cohort 1: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) of ≤ 40%.
Cohort 2: Heart failure (HF) participants with left ventricular ejection fraction (LVEF) > 40% and ≤ 65%.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with New York Heart Association (NYHA) Class II-III.
- •Cohort 1 - Left Ventricular Ejection Fraction (LVEF) ≤ 40%.
- •Cohort 2 - Left Ventricular Ejection Fraction (LVEF) >40% and ≤ 65%, elevated N-terminal pro B-type natriuretic peptide (NT-proBNP) ≥ 600pg/mL and atrial fibrillation/flutter.
- •Stable heart failure and on optimal medical therapy.
- •Screening hemoglobin ≥ 9.0 g/dL.
排除标准
- •Uncontrolled hypertension.
- •Sustained systolic Blood Pressure (BP) < 90 mmHg and/or diastolic BP < 50 mmHg on 2 consecutive (duplicate seated) readings at screening.
- •Heart failure due to hypertrophic cardiomyopathy, restrictive and/or infiltrative cardiomyopathy, arrhythmogenic right ventricular dysplasia, Fabry disease, or Noonan syndrome with LV hypertrophy or a positive serum immunofixation result.
- •Diagnosis of stress-induced (Takotsubo) cardiomyopathy, myocarditis, or peripartum cardiomyopathy.
- •Diagnosis of chemotherapy- or radiation-induced cardiomyopathy.
- •Diagnosed with stroke or Transient Ischemic Attack (TIA) within 12 weeks of screening.
- •History of syncope within the last 12 weeks prior to screening or sustained ventricular tachycardia without an implantable cardioverter-defibrillator.
- •Moderate or severe aortic and/or mitral valve stenosis.
- •Medically documented unstable angina, acute coronary syndrome (e.g., myocardial infarction, troponin-positive with symptoms of angina or unstable angina) within the last 8 weeks prior to start of screening.
- •Medically documented ST-elevation myocardial infarction within 12 weeks of screening.
- •Any tachycardia (inclusive of Atrial Fibrillation (AF) or atrial flutter) with a resting ventricular rate > 110 beats per minute at screening.
- •For participants with a history of AF or atrial flutter, not on adequate anticoagulant therapy via non-vitamin K oral anticoagulants or warfarin if the CHA2DS2-VASc score is ≥ 2 in men or ≥ 3 in women or per local guidelines. Percutaneous occlusion of the left atrial appendage alone is not adequate.
- •AF ablation within the last 12 weeks prior to screening or planned during the study duration.
- •Symptomatic bradycardia or second (Mobitz Type II)- or third-degree heart block without a pacemaker.
- •Cardiac surgery, coronary artery revascularization or indication for coronary artery revascularization, percutaneous coronary intervention, valve repair/replacement or valvuloplasty within 12 weeks prior to screening.
- •Implantation of a Cardiac Resynchronization Therapy (CRT) device within 12 weeks prior to screening, or intent to implant a CRT device during the course of the study.
- •Previous cardiac transplantation, or any use of mechanical circulatory support or similar device, or implantation expected after randomization.
- •Receiving mechanical hemodynamic support or invasive mechanical ventilation within the last 8 weeks prior to screening.
- •Receiving Intravenous (IV) inotropes or IV vasopressors within the last 8 weeks prior to screening.
- •Receiving IV vasodilators within the last 4 weeks prior to screening.
- •Receiving noninvasive mechanical ventilation within the last 4 weeks prior to screening. The use of noninvasive ventilation for sleep disordered breathing is permitted.
研究组 & 干预措施
JK07 high dose
Active Comparator
JK07 administered by intravenous (IV) infusion
干预措施: JK07 (Drug)
Placebo
Placebo Comparator
Placebo administered by intravenous (IV) infusion
干预措施: Placebo (Drug)
JK07 low dose
Active Comparator
JK07 administered by intravenous (IV) infusion
干预措施: JK07 (Drug)
结局指标
主要结局
Safety - Cohort 2
时间窗: Study entry through week 52
Incidence and severity of treatment emergent adverse events
Safety - Cohort 1
时间窗: Study entry through week 52
Incidence and severity of treatment emergent adverse events
Efficacy - Cohort 1
时间窗: Baseline through week 26
Change in LVEF measured by 2D-TTE
次要结局
未报告次要终点
研究者
研究点 (124)
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