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NCT07076615CompletedPhase 4

The Effect of Dapagliflozin on Patients With Cardiomyopathy

Source: ClinicalTrials.gov · Last updated 15 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
100 (actual)
First submitted
15 Apr 2025
Start date
1 Aug 2025
Primary completion date
31 May 2026
Lead sponsor
May Mohamed Abdalla
NCT number
NCT07076615

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 100
  • From 1 Aug 2025 to the primary completion date, 31 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Type 1 diabetes mellitus
  • Urinary tract or genital infection
  • History of hypersensitivity to any SGLT2 inhibitor
  • Severe hepatic impairment (Child-Pugh class C)

Lab values

  • Serum glucose \< 80 mg/dL at enrollment

Other

  • Hypovolemia
  • Diabetic ketoacidosis
  • Systolic blood pressure \< 90 mmHg at enrollment
  • Pregnant or breastfeeding women
  • Severe primary valvular lesion requiring intervention
  • Estimated glomerular filtration rate \< 25 mL/min/1.73 m² (by MDRD equation)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cairo University
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.