The Effect of Dapagliflozin on Patients With Cardiomyopathy
May Mohamed Abdalla
100 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
Summary
This randomized controlled trial evaluates the efficacy and tolerability of early initiation of dapagliflozin in adult patients hospitalized with acute heart failure (AHF). The study aims to assess the effect of dapagliflozin on pulmonary congestion as measured by lung ultrasound (LUS), length of hospital stay, and cardiac and renal biomarkers. A total of 100 patients will be randomized into two groups: one receiving dapagliflozin plus diuretics and the other receiving diuretics alone. Key outcomes include the reduction of extravascular lung water (assessed by B-lines in LUS), improved diuretic response, changes in NT-proBNP, sST2, CA-125, and NGAL levels, and incidence of acute kidney injury. The study will be conducted at the Cardiology and ICU departments at Kasr Al Ainy Hospital, Cairo University
Eligibility
Inclusion Criteria5
- years or older
- Acute heart failure as defined by the 2022 American College of Cardiology/American Heart Association (Heidenreich et al., 2022) or 2021 European Society of Cardiology (McDonagh et al., 2021) guidelines, based on typical symptoms and signs of heart failure requiring hospitalization or emergency department visit
- Elevated natriuretic peptide levels
- Includes heart failure with reduced, mildly reduced, or preserved ejection fraction
- Planned use of intravenous diuretic therapy
Exclusion Criteria11
- Type 1 diabetes mellitus
- Urinary tract or genital infection
- Hypovolemia
- Diabetic ketoacidosis
- Serum glucose \< 80 mg/dL at enrollment
- Systolic blood pressure \< 90 mmHg at enrollment
- History of hypersensitivity to any SGLT2 inhibitor
- Pregnant or breastfeeding women
- Severe primary valvular lesion requiring intervention
- Severe hepatic impairment (Child-Pugh class C)
- Estimated glomerular filtration rate \< 25 mL/min/1.73 m² (by MDRD equation)
Interventions
Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy
Arm B (Control Group): Receives standard intravenous diuretic therapy alone
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07076615