RecruitingPhase 2NCT07192211

Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo CABG

Exploratory Study of ADR-002K for Heart Failure Patients With Ischemic Heart Disease Who Undergo Coronary Artery Bypass Surgery

Sponsor

Rohto Pharmaceutical Co., Ltd.

Enrollment

50 participants

Start Date

Apr 28, 2026

Study Type

INTERVENTIONAL

Conditions

Ischemic Heart Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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.
Others

Exclusion Criteria3

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.
Others

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Interventions

BIOLOGICALMesenchymal stem cell

ADR-002K administration

BIOLOGICALPlacebo

Placebo

Locations(1)

The University of Osaka Hospital

Osaka, Suita, Japan

View Full Details on ClinicalTrials.gov

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NCT07192211

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