Effect of empagliflozin for HFpEF with Type2 DM

JRCT ID: jRCTs071180091

Registered date:29/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type2 DM
• Date of first enrollment: 08/12/2017
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Treatment

Outcome(s)

• Primary Outcome: Aim of this study is to investigate whether empagliflozin could improve heart failure (HF) of T2DM patients with HFpEF (heart failure with preserved ejection fraction). Severity and improvement of HF is evaluated by oxygen uptake efficiency (Peak VO2) obtained during the submaximal portion of cardiopulmonary exercise testing (CPET), which is one of the most reliable and accurate parameter of HF severity.
• Secondary Outcome: Secondary objectives are to explore underlying mechanism and relevant factors contributing to cardioprotection of empagliflozin by evaluating the following changes at the start of the study and 12 weeks later such as: anaerobic threshold (AT; testing by CPET), BNP, NYHA, LVEF and RVEF(by MRI), muscle mass by body composition test (by In Body 770K), grip strength and ower extremity muscle strength, BDNF, and L-FABP.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1)Age >20 years and <85 years males and females
2)Inadequately controlled type 2 diabetic patients HbA1c >= 6.0% and HbA1c < 10%
3)Type 2 diabetic patients with LV ejection fraction > 50% and a symptom of heart failure (NYHA II or III)
4)BNP >= 35pg/dL
5)Patients from whom a written informed consent are obtained

Exclude criteria

1)Other than T2DM such as T1DM and secondary DM.
2)Patients with severe infection, perioperative patients, patients with severe trauma.
3)Patientsreceiving SGLT2 inhibitor and/or incretin-related drugs within 2 months before ingestion of study drug.
4)Patients with idiopathic cardiomyopathy, Fabry disease, Amyloidosis cardiomyopathy.
5)Patientswithrenal insufficiency (eGFR< 45 ml/min/1.73m2).
6)Patients with severe respiratory disease, severe musculoskeletal conditions and unable to exercise challenge test for any other diseases, and severe anemia.
7)Any uncontrolled endocrine disorder except type 2 diabetes.
8)Acute coronary syndrome, stroke, or transient ischemic attack within 3 months of IC.
9)Patient who is scheduled to undergo surgery within 3 months before IC or plan to operate within 3 months after IC.
10)Patients who have a heart pacemaker, who have an aneurysm clip in their brain more than 20 years ago, or have a body implantationdevice(Implantedcardioverter-defibrillator ,Cochlear,otologic,or other ear implant, or Neurostimulation system).
11)Patients with severe claustrophobia.
12)Patients who are pregnant or breast-feeding.
13)Patients lower than BMI 20.
14)Patients in hyperglycemic crisis or accompanied with marked symptom of hyperglycemia and /or DKA.
15)Patients considered inappropriate to participate in the study by the principal and/or sub- investigators.

Related Information

• Primary Sponsor: Shiose Akira
• Source(s) of Monetary Support: Boehringer Ingelheim