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Recruiting NCT07192211

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

Phase II Interventional Ischemic Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mesenchymal stem cell, Placebo.
Who it may be relevant to
Registry conditions: Ischemic Heart Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Biological Mesenchymal stem cell
    ADR-002K administration
  • Biological Placebo
    Placebo

Primary outcome measures

  • Time to the first occurrence of the cardiovascular events [Time frame: 2 years]
Secondary outcome measures (9)
  • Left Ventricular Ejection Fraction (LVEF) in Cardiac MRI scan and Echocardiography [Time frame: 2years]
  • Late Gadolinium Enhancement (LGE) in Cardiac MRI scan [Time frame: 2 years]
  • Left Ventricular Remodeling in Cardiac MRI scan & Echocardiography [Time frame: 2 years]
  • 6-minute walk distance [Time frame: 2 years]
  • New York Heart Association Symptoms [Time frame: 2 years]
  • The Kansas City Cardiomyopathy Questionnaire（KCCQ) [Time frame: 2 years]
  • Minesota Living With Heart Failure Questinanaire（MLHFQ） [Time frame: 2 years]
  • N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) [Time frame: 2 years]
  • Adverse Events [Time frame: 2 years]

Eligibility criteria

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.
  • Others

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.
  • Others

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • The University of Osaka Hospital — Osaka

Identifiers

NCT: NCT07192211 · ADR-002K-0223

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗