Heart failure with preserved ejection fraction in type 2 diabetes mellitus
Conditions
Interventions
Interventions (The group with Canagliflozin) The period of intervention: 0-24 weeks. The dosage of Canagliflozin: 100mg/day.
Control (The group without Canagliflozin)
Sponsors
Nara Medical Univercity
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are the patients who need oral hypoglycemic agents (OHA) even after diet and exercise therapy, and who need additional OHA in other OHA users than SGLT2 inhibitor. Inclusion criteria 1) Informed consent (IC) from the patient him/herself. 2) >=65 year-old (Female/Male) 3) HbA1c >=6.5%, and HbA1c <10.0% within 8 weeks. HbA1c >=7.0% in case of administration of sulfonylurea, and/or glinide 4) History of heart failure before consent, and echocardiographic mean E/e' >14 (septal E/e' >15, or lateral E/e' >13 ) , or septal e' <7 cm/min, or lateral e' <10 sec/min and LV ejection fraction >=50%, with or without atrial fibrillation (AF) 5) Plasma BNP >=100 pg/mL or plasma NT-proBNP >=400 pg/mL before consent, or plasma BNP >=40 pg/mL or plasma NT-proBNP >=125 pg/mL within 8 weeks before consent, with or without atrial fibrillation (AF) 6) NYHA II or III (<8 weeks from IC) 7) No history of change in drug regimens (<8 weeks from IC)
Exclusion criteria
Exclusion criteria: Exclusion criteria 1) Type 1 DM 2) Treated with GLP-1 3) Patients who need insulin (severe ketosis, diabetic coma or pre-coma, severe infection, peri-operative, severe trauma) 4) Severe renal dysfunction or chronic renal failure during dialysis (In case of moderate renal dysfunction, patients are carefully judged the need for administration of canagliflozin) 5) ACS, CVD, myocarditis, contractile pericarditis, severe HVD (<12 weeks from IC) 6) NYHA IV 7) BMI<18.5kg/ m2 8) The pregnant, breastfeeder 9) Diagnosed or suspected malignant tumors (Patients who did not treat anti-cancer treatment within 1 year before consent can be entered.) 10) Inappropriate patients inappropriate to be included for some reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The change in BNP at week 24 from the baseline. 2) The change in body weight at week 24 from the baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Hospitalization for heart failure 2) Cardiovascular death / total death 3) The change of body weight at each measurement point from the baseline. 4) The change of dose under loop diuretics. 5) The change in HbA1c from the baseline. 6) The change in BNP and NT-proBNP at each measurement point from the baseline. 7) Echocardiography 8) CONUT score and GNRI 9) FT3, FT4, TSH | — |
Countries
Japan
Contacts
Public ContactMasato Kasahara
Nara Medical University Hospital Institute for Clinical and Translational Science
Outcome results
None listed