NCT07076615

The Effect of Dapagliflozin on Patients With Cardiomyopathy

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: May Mohamed Abdalla · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Acute Heart Failure (AHF) is a life-threatening syndrome and a leading cause of hospitalization worldwide. Effective decongestion during AHF episodes is essential for improving patient outcomes and reducing hospital readmissions. Sodium-glucose co-transporter 2 (SGLT2) inhibitors, particularly dapagliflozin, have shown significant promise in improving cardiovascular outcomes in chronic heart failure; however, their role during acute episodes remains under active investigation. This prospective, randomized controlled trial aims to assess the efficacy and safety of early dapagliflozin initiation in hospitalized adult patients with AHF, irrespective of diabetes status. A total of 100 patients admitted to the Cardiology and Intensive Care Departments of Kasr Al Ainy Hospital, Cairo University, will be enrolled and randomized (1:1) to either standard diuretic therapy alone or dapagliflozin (10 mg once daily) plus diuretics. The study's primary endpoint is the degree of pulmonary congestion, evaluated through lung ultrasound (LUS) using an 8-zone scanning protocol and quantification of B-lines. Secondary outcomes include hospital length of stay, diuretic response, changes in cardiac biomarkers (NT-proBNP, sST2, and CA-125), renal biomarker NGAL, and incidence of acute kidney injury. LUS and echocardiography will be performed by certified intensivists using standardized protocols. Biomarkers will be measured via ELISA kits at three time points: within 24 hours of admission, and at discharge. The hypothesis is that early use of dapagliflozin in AHF enhances decongestion, improves natriuretic response, and enables earlier hospital discharge without increasing adverse renal or metabolic events. The results of this study will provide valuable insights into the use of SGLT2 inhibitors during the acute phase of heart failure and may inform future clinical practice guidelines.

Conditions

• Acute Decompensated Heart Failure (ADHF)

Interventions

Type	Name	Description
DRUG	Dapagliflozin (DAPA)	Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy
DRUG	Diuretic	Arm B (Control Group): Receives standard intravenous diuretic therapy alone

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-07-22
• Last updated: 2025-08-22

Locations

1 site across 1 country: Egypt