Early dapagliflozin plus diuretics for adults hospitalized with acute heart failure
The Effect of Dapagliflozin on Patients With Cardiomyopathy
This trial will see if starting dapagliflozin early, together with standard diuretics, helps adults hospitalized with acute heart failure clear lung fluid faster, shorten hospital stay, and protect heart and kidney function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07076615 on ClinicalTrials.gov |
What this trial studies
This is a prospective, randomized controlled trial enrolling 100 adults hospitalized with acute heart failure at Kasr Al Ainy Hospital, Cairo University, randomized 1:1 to dapagliflozin 10 mg once daily plus standard diuretics versus diuretics alone. The primary endpoint is change in pulmonary congestion measured by lung ultrasound B-lines using an 8-zone protocol, with secondary endpoints including hospital length of stay, diuretic response, changes in NT-proBNP, sST2, CA-125, NGAL, and incidence of acute kidney injury. Lung ultrasound and echocardiography will be performed by certified intensivists and biomarkers measured by ELISA at predefined time points during hospitalization. The trial includes patients regardless of ejection fraction or diabetes status, with standard safety exclusions for SGLT2 inhibitors.
Who should consider this trial
Good fit: Adults (≥18 years) hospitalized for acute heart failure with elevated natriuretic peptides and planned intravenous diuretic therapy who do not meet exclusion criteria such as type 1 diabetes or severe renal impairment are the intended participants.
Not a fit: Patients with type 1 diabetes, severe renal impairment (eGFR <25 mL/min/1.73 m²), systolic blood pressure <90 mmHg, active urinary/genital infection, pregnant or breastfeeding women, or severe valvular disease are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, early dapagliflozin could speed decongestion, reduce time in hospital, and lower cardiac and renal biomarker worsening in patients with acute heart failure.
How similar studies have performed: SGLT2 inhibitors like dapagliflozin have shown clear benefits in chronic heart failure, but evidence for routine early use during acute decompensation is limited and remains under active investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: May M Abdalla, Senior teaching assistant
- Email: mayezzeldin@miuegypt.edu.eg
- Phone: 002 01002662985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.