The Effect of Dapagliflozin on Patients With Cardiomyopathy

Sponsor
May Mohamed Abdalla
Study ID
NCT07076615
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Acute Decompensated Heart Failure (ADHF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Aug 31, 2025
Status verified
Aug 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS) [ Time Frame: Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission) ]

Central Contacts