IMeglimin for exercise CApacity in Patients with HF and diabetes
Not Applicable
Recruiting
- Conditions
- Heart failure with diabetes mellitusHeart Failure, Diabetes Mellitus
- Registration Number
- JPRN-jRCTs031220712
- Lead Sponsor
- aito Ryo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 44
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in peak oxygen consumption assessed by cardiopulmonary exercise testing from baseline to week 12 after intervention
- Secondary Outcome Measures
Name Time Method -Change in ventilatory equivalent for carbon dioxide slope assessed by cardiopulmonary exercise testing<br>-Change in N-terminal pro-brain natriuretic peptide levels from baseline to week 12 after intervention<br>-Change in left ventricular ejection fraction and left ventricular diastolic function assessed by echoca<br>rdiography from baseline to week 12 after intervention<br>-Change in fasting blood glucose levels from baseline to week 12 after intervention<br>-Change in glycated hemoglobin levels from baseline to week 12 after intervention<br>-Hospitalization for heart failure<br>-Incident cardiovascular death