Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07076615

The Effect of Dapagliflozin on Patients With Cardiomyopathy

Led by May Mohamed Abdalla · Updated on 2025-08-22

100

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

Sponsors

M

May Mohamed Abdalla

Lead Sponsor

C

Cairo University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

The Effect of Dapagliflozin on Patients With Cardiomyopathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with acute heart failure based on 2022 ACC/AHA or 2021 ESC guidelines requiring hospitalization or emergency visit
  • Elevated natriuretic peptide levels
  • Includes heart failure with reduced, mildly reduced, or preserved ejection fraction
  • Planned treatment with intravenous diuretics
Not Eligible

You will not qualify if you...

  • Diagnosis of type 1 diabetes mellitus
  • Current urinary tract or genital infection
  • Presence of hypovolemia
  • Diabetic ketoacidosis
  • Serum glucose below 80 mg/dL at enrollment
  • Systolic blood pressure below 90 mmHg at enrollment
  • History of hypersensitivity to any SGLT2 inhibitor
  • Pregnant or breastfeeding women
  • Severe primary valvular lesion requiring intervention
  • Severe liver impairment (Child-Pugh class C)
  • Estimated glomerular filtration rate below 25 mL/min/1.73 m²

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, Egypt

Actively Recruiting

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Research Team

M

May M Abdalla, Senior teaching assistant

CONTACT

A

Ahmed M Kamal, Lecturer of Cardiovascular

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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