The Effect of Dapagliflozin on Patients With Cardiomyopathy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Egypt
Cairo University
RECRUITING
Cairo
Contact Information
Primary
May M Abdalla, Senior teaching assistant
mayezzeldin@miuegypt.edu.eg
002 01002662985
Backup
Ahmed M Kamal, Lecturer of Cardiovascular
dr.ahmedkamal10@gmail.com
002 01001284924
Time Frame
Start Date: 2025-08
Estimated Completion Date: 2026-05
Participants
Target number of participants: 100
Treatments
Experimental: Dapagliflozin + Diuretic (Intervention Group)
Participants will receive dapagliflozin 10 mg orally once daily in addition to standard intravenous diuretic therapy.~Intervention(s):~Drug: Dapagliflozin (DAPA)~Dose: 10 mg once daily~Route: Oral~Other Name(s): Forxiga~Drug: Intravenous Diuretic~Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol
Active_comparator: Active Comparator
Participants will receive standard intravenous diuretic therapy alone, without dapagliflozin.~Intervention(s):~Drug: Intravenous Diuretic~Standard care intravenous loop diuretics (e.g., furosemide) according to clinical protocol
Related Therapeutic Areas
Sponsors
Leads: May Mohamed Abdalla
Collaborators: Cairo University

This content was sourced from clinicaltrials.gov