An exploratory study of dapagliflozin for the attenuation of albuminuria in patients with heart failure and type 2 diabetes mellitus
- Conditions
- Type 2 Diabetes Mellitus patients with Chronic Heart Failure
- Registration Number
- JPRN-UMIN000025102
- Lead Sponsor
- Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Center, 5-7-1 Fujishiro-dai, Suita, Osaka, 5658565, Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 288
Not provided
1) Patients with insulin treatment 2) Patients with an allergic history of dapagliflozin 3) Patients with a history of severe diabetic ketoacidosis, diabetic coma or pre-coma 4) Patients using mechanical circulatory support devices 5) Patients waiting for heart transplant 6) Patients waiting for cardiac surgery 7) Patients who may easily show dehydration, including a history of dehydration, highly frequent change of diuretics, extreme thinness 8) Patients with hepatic dysfunction with AST or ALT 3-fold of upper limit of normal (ULN) at screening (However, if increased AST or ALT is determined to be attributable to cardiac diseases, patients do not meet this exclusion criterion as long as total bilirubin levels are < 3.0 mg/dL.) 9) Patients with bilateral renal artery stenosis or renal artery stenosis in a solitary kidney 10) Patients in a serious clinical condition and who are expected to live for < 3 years 11) Patients with possible alcohol or drug abuse 12) Patients who are pregnant or possibly pregnant 13) Patients with breast feeding 14) Patients who have been enrolled in other clinical studies at the same time with this study (excluding observational studies such as registry studies) 15) Patients who are judged by the investigator or subinvestigators to be not suitable for participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The magnitude of the change in urinary albumin creatinine ratio after 2 years observation from the baseline
- Secondary Outcome Measures
Name Time Method