diabetes Mellitus and chronic heart failure
Conditions
Interventions
A arm to which an additional dose of Ipragliflozin L-Proline was administered.
Regular anti-diabetic drugs other than SGLT-2 inhibitors arm.
Sponsors
Osaka University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.diabetes Mellitus with NT-proBNP> 125 pg / mL and chronic heart failure (NYHA function classification 1 - 3). 2.Within the last 3 months,not administered the SGLT2 inhibitor. 3.Aged < 65years:HbA1c 7%<=and < 10% ,Aged >= 65years:HbA1c 7.5%<= and < 10%. 4.Aged >= 20 and < 75years. 5.Outpatient. 6.Any gender. 7.Provision of written consent.
Exclusion criteria
Exclusion criteria: 1.Acute exacerbation patients with chronic heart failure. 2.Within 3 months,stroke,Acute coronary syndrome,And percutaneous coronary angioplasty,coronary artery bypass surgery. 3.LVEF<50% and Severe valvular disease. 4.Concurrent Atrial fibrillation. 5.Severe liver dysfunction(Chronic hepatitis C etc). 6.Severe Kidney failure or eGFR <30mL/min/1.73m2 7.Concurrent malignancy. 8.Concurrent dementia. 9.State requiring nursing care. 10.Pregnancy or possible pregnancy. 11.SGLT2 inhibitors medicine contraindications. 12.Inappropriateness as a subject of this trial as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in echocardiography-based cardiac function test parameters( E/e',e') | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in echocardiography-based cardiac function test parameters (LVMI,LAD,LAV,LVEF,LVEDV,LVESV,E/A,IVC) Change in NT-proBNP Change in NYHA Functional Classification and other assessments | — |
Countries
Japan
Contacts
Public ContactKen Sugimoto
Osaka University Graduate School of Medicine Geriatric and General Medicine
Outcome results
None listed