Canagliflozin heart failure with preserved ejection fraction study in type 2 diabetes mellitus

Not Applicable

• Conditions: Heart failure with preserved ejection fraction in type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000028668
• Lead Sponsor: ara Medical Univercity

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-01
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) The change in BNP at week 24 from the baseline. 2) The change in body weight at week 24 from the baseline.

Secondary Outcome Measures

Name	Time	Method
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