Yokohama Add-on Inhibitory Efficacy of Dapagliflozin on Left Ventricular Filling Pressure in Patients with Acute Heart Failure with Preserved Ejection Fraction Complicated with type 2 Diabetes Study

UMIN ID: UMIN000038380

Registered date:25/10/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute heart filure with preserved ejection fraction complicated with type 2 diabetes mellitus
• Date of first enrollment: 2016/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Dapagliflozin for 12 weeks
Alogliptin for 12 weeks

Outcome(s)

• Primary Outcome: Diastolic parameters of echocardiography after 12 weeks ; including left ventricular filling pressure
• Secondary Outcome: BNP, Cr, eGFR, Urinalysis, Endopat, PWV, events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: (1)type1 DM (2)pregnancy (3)CKD stage4, 5 (4)CPK>3 folds of normal range (5)hepatic injury (6)NYHA4, oxygenation, intravenous treatment (7)diabetic ketoacidosis (8)serious infection (9)systemic anesthesia, post surgery (10)sensitive for dapaglifrozin or allogiptin (11)SGLT2 inhibitor or Dpp4 inhinitor, but they are applicable if in case HbA1c control is not good (12)incapable controllable DM (13)pregnancy (14)if clinician thinks they are not applicable

Related Information

• Primary Sponsor: Yokohama city university medical center
• Secondary Sponsor: Yokohama City University Hospital
• Source(s) of Monetary Support: Yokohama City University