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Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery

Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery - Phase I trial of ADR-002K for patients with ischemic cardiomyopathy who undergo coronary artery bypass surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000038809
Enrollment
6
Registered
2019-12-06
Start date
2019-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Cardiomyopathy

Interventions

Bypass surgery and test product administration Bypass surgery and placebo administration

Sponsors

Osaka University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who are clinically diagnosed with ischemic cardiomyopathy and receive CABG 2) Patients with a left ventricular ejection fraction of 40% or less by cardiac ultrasonography within 4 weeks before obtaining consent 3) Others

Exclusion criteria

Exclusion criteria: 1) Patients who have a combination of cardiovascular disease such as severe organic valvular disease or aortic aneurysm determined by investigator or co-investigator to affect clinical trial procedure 2) Patients whose participation in a clinical trial is considered inappropriate at the discretion of the investigator or co-investigator 3) Others

Design outcomes

Primary

MeasureTime frame
1) Adverse event and safety evaluation related to this product 2) Efficacy(exploratory) 3) Feasibility

Secondary

MeasureTime frame
1) Cardiac function 2) Exercise tolerance 3) Other

Countries

Japan

Contacts

Public ContactDaisuke MORI

Osaka University Hospital Department of Cardiovascular Surgery

d-mori@surg1.med.osaka-u.ac.jp06-6879-3154

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026