Heart failure with diabetes mellitus Heart Failure, Diabetes Mellitus
Conditions
Interventions
Oral administration of imeglimin (1000mg) or placebo twice daily
imeglimin, placebo
Sponsors
Naito Ryo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in peak oxygen consumption assessed by cardiopulmonary exercise testing from baseline to week 12 after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| -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 | — |
Contacts
Public ContactRyo Naito
Juntendo University Hospital
Outcome results
None listed