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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRohto Pharmaceutical Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mesenchymal stem cell

    Biological/Vaccine

    ADR-002K administration

  • Placebo

    Biological/Vaccine

    Placebo

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Mesenchymal stem cellExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to the first occurrence of the cardiovascular events

Time frame
2 years

Secondary outcomes

1

Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography

Changes of LVEF in 2years after ADR-002K administration

Time frame
2years
2

Late Gadolinium Enhancement (LGE) in Cardiac MRI scan

Changes of LGE in the 2years after ADR-002K administration

Time frame
2 years
3

Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography

Changes of Left Ventricular End-Systolic Volume Index, Left Ventricular End-Diastolic Volume Index, Left Ventricular End-Systolic Diameter, Left Ventricular End-Diastolic Diameter) in 2 years after ADR-002K administration

Time frame
2 years
4

6-minute walk distance

Changes of 6-minute walk distance in 2 years after ADR-002K administration

Time frame
2 years

Other outcomes

Sponsors and contacts

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