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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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0008535
Enrollment
30
Registered
2023-06-16
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The study is scheduled to be conducted on adults aged 19 to less than 85 years with an increased epicardial fat thickness of 5 mm or more on transthoracic echocardiography among heart failure p

Sponsors

Kangbuk Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - = 18 years and 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

Exclusion criteria

Exclusion criteria: - 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 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

Design outcomes

Primary

MeasureTime frame
Epicardial adipose tissue thickness

Secondary

MeasureTime frame
NT-proBNP;Heart failure related health status using the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score;Body weight

Countries

Korea, Republic of

Contacts

Public ContactHyo-In Choi

Kangbuk Samsung Medical Center

sinclair0119@naver.com+82-2-2001-2596

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026