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Imeglimin for exercise capacity in patients with heart failure and diabetes

IMeglimin for exercise CApacity in Patients with HF and diabetes (IMCAP-HF)

Naito Ryo

Juntendo University Hospital

3-1-3, Hongo, Bunkyo-ku, Tokyo

rnaitou@juntendo.ac.jp

Naito Ryo

Juntendo University Hospital

3-1-3, Hongo, Bunkyo-ku, Tokyo

+81-338133111

rnaitou@juntendo.ac.jp

Recruiting

Mar. 17, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Age 20 and greater
-Diagnosed with heart failure and diabetes mellitus
-Under outpatient cardiac rehabilitation program
-Under no treatments or one anti-diabtic agent for diabetes mellitus
-Written informed consent provided

-Hypersensitivity to Imeglimin
-Diabetic coma or severe ketosis
-Type 1 diabetes
-Severe infectious disease
-Renal dysfunction (eGFR<45 mL/min/1.73 m2 or under dialysis)
-Pregnancy
-Nursing
-Any participant judged not suitable for this study by investigators

Both

Heart failure with diabetes mellitus

Oral administration of imeglimin (1000mg) or placebo twice daily

Heart Failure, Diabetes Mellitus

imeglimin, placebo

Heart Failure, Diabetes Mellitus

imeglimin, placebo

Change in peak oxygen consumption assessed by cardiopulmonary exercise testing from baseline to week 12 after intervention

-Change in ventilatory equivalent for carbon dioxide slope assessed by cardiopulmonary exercise testing
-Change in N-terminal pro-brain natriuretic peptide levels from baseline to week 12 after intervention
-Change in left ventricular ejection fraction and left ventricular diastolic function assessed by echoca
rdiography from baseline to week 12 after intervention
-Change in fasting blood glucose levels from baseline to week 12 after intervention
-Change in glycated hemoglobin levels from baseline to week 12 after intervention
-Hospitalization for heart failure
-Incident cardiovascular death

+81-3-5802-1584

Feb. 07, 2023

Yes

Undecided

none