NCT07192211招募中2 期
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo Coronary Artery Bypass Surgery
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to the first occurrence of the cardiovascular events
研究概览
简要总结
ADR-002K is administered to heart failure patients with ischemic heart disease who undergo coronary artery bypass surgery (CABG) to investigate its efficacy and safety.
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled Phase II study. ADR-002K (Adipose-derived mesenchymal stem cells) is administered to the surface of the heart in patients with ischemic heart disease who undergo CABG. The efficacy and safety of ADR-002K are evaluated until the last patient has completed the 2-year evaluation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients clinically diagnosed with chronic heart failure due to ischemic heart disease who undergo CABG
- •Patients with an LVEF of less than 40% as determined by the cardiac ultrasound at the screening examination.
排除标准
- •Patients who have a combination of cardiovascular disease such as severe organic valvular disease.
- •Patients who have developed acute coronary syndrome within 3 months prior to obtaining consent.
研究组 & 干预措施
Mesenchymal stem cell
Experimental
干预措施: Mesenchymal stem cell (Biological)
Placebo
Placebo Comparator
干预措施: Placebo (Biological)
结局指标
主要结局
Time to the first occurrence of the cardiovascular events
时间窗: 2 years
次要结局
- Late Gadolinium Enhancement (LGE) in Cardiac MRI scan(2 years)
- Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography(2years)
- Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography(2 years)
- 6-minute walk distance(2 years)
- New York Heart Association(2 years)
- The Kansas City Cardiomyopathy Questionnaire（KCCQ)(2 years)
- N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)(2 years)
- Adverse Events(2 years)
- Minesota Living With Heart Failure Questinanaire（MLHFQ）(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Exploratory Study of ADR-002K for Heart Failure Patients with Ischemic Heart Disease who Undergo Coronary Artery Bypass SurgeryjRCT2053250022ROHTO Pharmaceutical Co., Ltd.50
终止
2 期
Effectiveness of CRD-740 in Heart FailureHeart FailureHeart Failure With Reduced Ejection FractionHeart Failure With Preserved Ejection FractionCardiovascular DiseasesHeart DiseasesNCT05409183Cardurion Pharmaceuticals, Inc.60
已完成
2 期
Ranolazine in Diastolic Heart FailureDiastolic Heart FailureNCT01163734Gilead Sciences20
已完成
2 期
Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease AloneHeart FailureNCT01955694Bayer72
已完成
不适用
Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in IndiaCTRI/2019/08/020629AstraZeneca Pharma India Ltd1,000