Type 2 diabetic patients with chronic heart failure
Conditions
Interventions
Oral administration of 5mg or 10mg dapagliflozin once a day, post breakfast
Sponsors
Division of Cardiovascular Medicine, Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 20 years and older and 75 years and yonger (male and female) 2) Is diagnosed with type 2 diabetes and the investigator considered that addition of dapagliflozin is possible 3) Is diagnosed with HbA1c 6.0-10.0% 4) Is diagnosed with chronic heart failure (NYHA class is I-III) 5) NYHA functional classification dosn't change in 4 weeks prior to eligibility qualification and dose of heart failure treatment drugs (such as ACE inhibitor, ARB, beta blocker, diuretic etc.) dosn't change 6) The patient provided written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Tpe 1 diabetis 2) Blood pressure of <90/50 mmHg 3) Has history of heart failure, acute coronary syndrome, cerebrovascular disease, myocarditis, constrictive pericarditis, or severe valvular disease within 4 months 4) Has history of uncontrolled atrial fibrillation or flutter within 1 month. 5) Has history of diabetic ketoacidosis, diabetic coma, or hypoglycemic attack within 6 months 6) Current use of insuline 7) With severe renal dysfunction (eGRF < 45 mL/min/1.73m 2 or patient undergoing artificial dialysis) 8) Has malignancy 9) With serious liver disfunction (AST or ALT is 3 times site reference value or more) 10) With pituitary gland dysfunction or adrenal gland dysfunction 11) With malnutrition, starvation, irregular eating pattern, lack of dietary intake, debilitaion 12) Pregnant, possibly pregnant, planned to become pregmant or nursing women 13) Has history of hypersensitivity to dapagliflozin, glimepiride or sulfonamides 14) Are considered not eligible for the study by the attending doctor due to other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular diastolic function by means of echocardiography after 6- and 12-month after administration of dapagliflozin (E/A, E/E', left atrial volume index and left ventricular mass index) | — |
Secondary
| Measure | Time frame |
|---|---|
| BNP after 6- and 12-month after administration of dapagliflozin | — |
Countries
Japan
Contacts
Public ContactHidekazu Tanaka
Kobe University Graduate School of Medicine Division of Cardiovascular Medicine
Outcome results
None listed