The Effect of Dapagliflozin on Patients With Cardiomyopathy
Recruiting · NCT07076615 · Interventional (participants receive a specific treatment) · Lead sponsor: May Mohamed Abdalla
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Inclusion criteria
- 18 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 criteria
- 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)
Where it is running
1 location listed.
- Cairo University - Cairo, Egypt