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

JRCT ID: jRCTs051180139

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 diabetes Mellitus and chronic heart failure
• Date of first enrollment: 30/10/2017
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Ipragliflozin L-proline,50mg/day

Outcome(s)

• Primary Outcome: change in the amount of E/e' , e' by echocardiography

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: RAKUGI HIROMI
• Source(s) of Monetary Support: Kotobuki Pharmaceutical Co., Ltd.
• Secondary ID(s): UMIN000027095