Status:
NOT_YET_RECRUITING
Dapagliflozin in Reducing Epicardial Adipose Tissue in Heart Failure with Preserved Ejection Fraction
Lead Sponsor:
Aswan University
Conditions:
Heart Failure with Preserved Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Heart failure with preserved ejection fraction (HFpEF) is becoming the most common cause of heart failure worldwide, in part, driven by a rising prevalence of obesity. Although generalized and viscer...
Eligibility Criteria
Inclusion
- Age \>18 years.
- Patients with established diagnosis of HFpEF: (1. Signs and Symptoms of Heart Failure. 2. Preserved Ejection Fraction (EF): EF greater than or equal to 50% is generally considered preserved. 3.Echo-cardiography: Evidence of left ventricular hypertrophy (LVH) or Evidence of diastolic dysfunction, such as impaired relaxation or increased stiffness of the left ventricle. 4.Elevated Natriuretic Peptides: serum N-terminal pro-B type natriuretic peptide (NT-proBNP) ≥400 pg/mL or brain natriuretic peptide ≥100 pg/mL can support the diagnosis of HFpEF in the presence of symptoms and other findings).
- BMI \>27Kg/m2.
- Adequate follow-up: Participants must be willing and able to comply with the study protocol and follow-up requirements.
Exclusion
- 1\. Age \<18 years. 2. Type 1 diabetes: Exclude individuals with type 1 diabetes, as dapagliflozin is primarily used for type 2 diabetes management.
- 3\. Significant renal impairment: Exclude participants with severe renal impairment or end-stage renal disease.
- 4\. Severe hepatic impairment: Exclude participants with severe hepatic dysfunction.
- 5\. Pregnancy or breastfeeding: Exclude pregnant or lactating individuals. 6. Patients who underwent Bariateric surgery. 7. BMI\<27Kg/m2. 8. Other serious medical conditions: Exclude participants with serious medical conditions that could interfere with the study or confound the results (e.g., cancer, severe infections).
- 9\. Inability to comply: Exclude participants who are unable or unwilling to comply with the study procedures and requirements.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06510270
Start Date
August 1 2024
End Date
October 1 2025
Last Update
July 19 2024
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