Effect of Dapagliflozin for Epicardial Adipose Tissue Reduction in Patients with Asymptomatic Heart Failure

Phase 3

Recruiting

• Conditions: Asymptomatic heart failure; Heart failure

• Registration Number: JPRN-jRCT1051220025
• Lead Sponsor: Tanaka Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-19
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1. Patients are aged 20 years or older.
2. Patients have consented to participate in the study and understand the procedures of the study.
3. Patients with asymptomatic heart failure (NYHAclass I).
4. Patients who are receiving at least one standardtherapy for heart failure (ACEI/ARB, MRA, or betablockr)
and have not changed the dose of the therapy within 2 weeks prior to enrollment.

Exclusion Criteria

1. Patients with a history of taking SGLT2 inhibitors.
2. Patients with a history of hypersensitivity to any component of Dapagliflozin.
3. Patients with type 1 diabetes mellitus.
4. Patients with significant anemia (hemoglobin less than 9g/dL).
5. Patients with serum AST/ALT/ALP levels exceeding the specified values (AST >150IU/L, ALT >150I
U/L, ALP >300U/L).
6. Patients with severe renal failure (eGFR less than 30ml/min/1.73m2).
7. Patients receiving systemic administration of steroids. Topical administration of steroids (application, local injection, inhalation, etc.) is acceptable.
8. Patients with a history of alcohol or drug abusewithin 3 months.
9. Patients with urinary tract/genital tract infections within 2 weeks.
10. Patients with severe aortic stenosis.
11. Patients with symptomatic coronary artery disease.
12. Patients scheduled to undergo cardiovascularsurgery within 24 weeks of enrollment.
13. Patients with systolic blood pressure of less than 90 mmHg.
14. Patients who are allergic to contrast media and cannot undergo contrast-enhanced CT.
15. Women who are pregnant, lactating, or who wish (or plan) to become pregnant.
16. Patients who are otherwise judged by the principal investigator or sub-investigator to be inappropriate for participation in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in EAT volume by cardiac contrast (or simple) CT imaging after 24 weeks of <br>enrollment.

Secondary Outcome Measures

Name	Time	Method
1. Time to onset of combined cardiovascular events (onset of heart failure syndrome + sudden death)<br>2. Change from baseline in left ventricular myocardial fibrosis volume, NT-proBNP, and high-sensitivity <br>C-reactive protein levels by contrast-enhanced CT imaging after 24 weeks of enrollment<br>3. Change from baseline in various parameters (LVEF, E wave velocity, A wave velocity, e' wave velocity) by<br> echocardiography after 24 weeks of enrollment.