Effect of SGLT2 inhibitor to epicardial adipose tissue thickness in patient with heart failure with left ventricular ejection fraction over 40% and increased epicardial adipose tissue thickness
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0008535
- Lead Sponsor
- Kangbuk Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
= 18 years and <85 years at screening
-Male or female patients
-Diagnosis of HF with EF = 40% which includes:
?Symptoms ± signs (as defined in 2016 European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure)
?Ejection fraction = 40% (by Simpson)
?Increased LV filling pressures at rest or during exercise determined by echocardiography (LV diastolic dysfunction grade II/III and/or positive diastolic stress test) [according to American Society of Echocardiography and European Association of Cardiovascular Imaging (ASE/EACVI) Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography, 2016]
-Elevated NT-proBNP > 225 pg/ml for patients without AF, OR > 375 pg/ml for patients with AF
-Both ambulatory and hospitalized patients
-Epicardial adipose tissue (EAT) thickness > 5 mm measured at end-diastole
-Signed and dated informed consent
-Patients being treated with any SGLT-2 inhibitor (dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) within the 8 weeks prior to the screening visit.
-Impaired renal function, defined as eGFR <20 ml/min/1.73 m² of body-surface-area (CKD-EPI)
-Systolic blood pressure > 180 mmHg or < 90 mmHg
-Other conditions that may be responsible for impaired diastolic function such as hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, complex congenital heart disease and etc.
-Planned cardiovascular revascularization (percutaneous intervention or surgical) or major cardiac surgery (coronary artery bypass grafting, valve replacement, ventricular assist device, cardiac transplantation, or any other surgery requiring thoracotomy, or transcatheter aortic valve replacement) or CRT within the 90 days after the screening visit.
-History of diabetic ketoacidosis
-Participation in any interventional clinical trial (with an investigational drug or device) that is not an observational registry within 15 days of the screening visit.
-History of hypersensitivity to SGLT2 inhibitors
-Indications of liver disease
-Type 1 Diabetes Mellitus (T1DM)
-Acute genital infection or urinary tract infection
-Current history of bladder cancer
-For women of child-bearing potential: Current or planned pregnancy or currently lactating
-Life expectancy <6 months at the screening visit
-Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Epicardial adipose tissue thickness
- Secondary Outcome Measures
Name Time Method T-proBNP;Heart failure related health status using the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score;Body weight