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

JRCT ID: jRCT1051220025

Registered date:19/05/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Asymptomatic heart failure
• Date of first enrollment: 05/08/2022
• Target sample size: 230
• Study type: Interventional

Intervention(s)

- SGLT2 inhibitor group
SGLT2 inhibitor (dapagliflozin, 10 mg orally once daily for 24 weeks) + standard heart failure treatment
- Standard therapy group
Standard heart failure treatment only
Patients with asymptomatic heart failure (aged 20years or older) who are appropriately treated with
standard heart failure therapies receive explanation about the study. After obtaining their written consent,
eligibility tests including cardiac contrast CTscan will be conducted during the screening period.
Eligible patients will be enrolled and randomized 1:1 to receive SGLT2 inhibitor (SGLT2 inhibitor
group: SGLT2 inhibitor plus standard heart failuretherapy) or no SGLT2 inhibitor (standard therapy
group: standard heart failure therapy). During the study treatment period, the SGLT2 inhibitor group will
receive dapagliflozin 10 mg once daily in addition to their existing heart failure medication, while
the standard therapy group will continue their existing heart failure medication. As the primary endpoint, at
the end of the treatment period (24 weeks after the enrollment date),the change from baseline (initial CT
image) in pericardial adiposity (EAT) volume as measured by contrast-enhanced (or simple) cardiac CT
imaging will be compared to verify superiority.

Outcome(s)

Primary Outcome

Change from baseline in EAT volume by cardiac contrast (or simple) CT imaging after 24 weeks of
enrollment.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Tanaka Atsushi