Examination for Cardiac function Effect by Echocardiography in Diabetes with chronic heart failure.

Not Applicable

• Conditions: Type 2 diabetes Mellitus and chronic heart failure; diabetes Mellitus

• Registration Number: JPRN-jRCTs051180139
• Lead Sponsor: RAKUGI HIROMI

Brief Summary

We conducted six months of RCT of ipragliflozin versus conventional treatment in 68 older T2D patients with heart failure with preserved ejection fraction. There was no significant improvement in diastolic function, echocardiographic measurements, plasma NT-proBNP levels, NYHA classification, HbA1c, or blood pressure in the ipragliflozin group compared with the conventional treatment group.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-19
• Study Completion: 2019-12-26
• Results First Posted: 2021-01-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

Type 2 diabetes patients with NT-proBNP> 125 pg / mL or BNP> 40 pg / mL and chronic heart failure (NYHA function classification I - III)

1.Within the last 3 months,not administered the SGLT2 inhibitor.
2.Aged < 65years:HbA1c 7%<=and < 10%
,Aged >= 65years:HbA1c 7.5%<= and < 10%.
3.Aged >= 20 and < 75years.
4.Outpatient.
5.Any gender.
6.Provision of written consent.

Exclusion Criteria

1.Acute exacerbation patients with chronic heart failure.
2.Within 3months, 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in the amount of E/e' , e' by echocardiography

Secondary Outcome Measures

Name	Time	Method
Amount of change in echocardiographic items (LVMI, LAD, LAV, LVEF, LVEDV, LVESV, E / A, IVC)<br> Amount of change of NT-proBNP<br> Changes in NYHA cardiac function classification<br> Amount of change in HbA1c and the amount of change in FBS<br> Amount of change in blood pressure<br> Frequency of SAE