NCT07192211RecruitingPhase 2
Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo Coronary Artery Bypass Surgery
Rohto Pharmaceutical Co., Ltd.1 site in 1 country50 target enrollmentStarted: April 28, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Time to the first occurrence of the cardiovascular events
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Biological)
Mesenchymal stem cell
Experimental
Intervention: Mesenchymal stem cell (Biological)
Outcomes
Primary Outcomes
Time to the first occurrence of the cardiovascular events
Time Frame: 2 years
Secondary Outcomes
- 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)
- 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)
- New York Heart Association Symptoms(2 years)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Exploratory Study of ADR-002K for Heart Failure Patients with Ischemic Heart Disease who Undergo Coronary Artery Bypass SurgeryHeart Failure Patients with Ischemic Heart Disease who Undergo Coronary Artery Bypass SurgeryjRCT2053250022ROHTO Pharmaceutical Co., Ltd.50
Terminated
Phase 2
Effectiveness of CRD-740 in Heart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Reduced Ejection FractionCardiovascular DiseasesHeart DiseasesHeart FailureNCT05409183Cardurion Pharmaceuticals, Inc.60
Completed
Phase 2
Ranolazine in Diastolic Heart FailureDiastolic Heart FailureNCT01163734Gilead Sciences20
Completed
Phase 2
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
Completed
Not Applicable
Study to assess the Prevalence of Heart Failure in Type 2 Diabetes Patients in IndiaType 2 diabetes mellitus without complications,CTRI/2019/08/020629AstraZeneca Pharma India Ltd1,000