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The Effect of Dapagliflozin on Patients With Cardiomyopathy

NCT07076615 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-08-22

No results posted yet for this study

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

Conditions

  • Acute Decompensated Heart Failure (ADHF)

Interventions

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

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • May Mohamed Abdalla

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07076615 on ClinicalTrials.gov