HFPEF patients with T2DM
Conditions
Interventions
Multicentered cohort study (PROBE study in multicenter) GroupA
sitagliptin (50/100mg/day) treatment Data accessment each 6 month for 2 years
Multicentered cohort study (PROBE study in multicenter) GroupB
therapeutic intervention by remedy except for DPP4 inhibitor. Data accessment each 6 month for 2 years
Sponsors
Department of Cardiology, Nagoya University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Aged 40 or above Male and female Ambulatory patient exhibiting his/her HbA1C value is between 6.0% and 8.9% Left ventricular ejection fraction assessed by echocardiography is more than 50% Left ventricular diastolic function parameters assessed by echocardiography satisfy the conditions as follows; #1 E/e more than 15 #2 E/e between 8 and 15 and NT-proBNP; more than 900pg/mL #3 E/e between 8 and 15 or NT-proBNP more than 900pg/mL and RAd-Ad more than 30msec. or LAVI more than 40mL/m2 or LVMImore than 110g/m2 in male and 100g/m2 in female
Exclusion criteria
Exclusion criteria: Major cardiovascular events within 3 months after registration Left ventricular ejection fraction is less than 50 percent Left ventricular diastolic diameter is more than 49mm Comorbid atrial fibrillation Diabetic patients who is treated by DPP-4 inhibitors and/or GLP-1analog Patients with CKD [eGFR less than 30ml] and ESRD Type 1 diabetes Malignancy within 5 years at registration Uncontrolled cormobid arrhythmia Uncontrolled cormobid hypertension Hospitalization within 6 month Diabetic patients who is treated by insulin Comorbid severe valuvular heart disease Comorbid severe ischemic heart disease Liver injury [ALT/AST values exhibit 5 times higher than normal range] Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in diastolic left ventricular function assessed by echocardiography (E/e') | — |
Secondary
| Measure | Time frame |
|---|---|
| Major cardiovascular event admission due to deteriarated heart failure changes in serum NT-proBNP value changes in biomarkers value changes in delayed enhancement observed each heart detected by cardiac MRI | — |
Countries
Japan
Contacts
Public ContactYasuko K Bando
Nagoya University Hospital Department of Cardiology
Outcome results
None listed