The Effect of Dapagliflozin on Patients With Cardiomyopathy

NCT07076615 | Recruiting Phase 4 DMC

• 2 other identifiers: N-73-2024PO.3.4.1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

ADHF

Outcome Measures

Primary Outcomes (1)

• Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS)

  To evaluate the effect of dapagliflozin on pulmonary congestion in patients hospitalized with acute heart failure, using lung ultrasound to measure the number of B-lines at defined intervals during hospitalization.

  Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission)

Secondary Outcomes (7)

• Effect of Dapagliflozin on Hospital Length of Stay

  From hospital admission to hospital discharge (an average of 7 days)

• Effect of Dapagliflozin on Renal Biomarker NGAL

  Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)

• Change in NT-proBNP Levels

  Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)

• Change in Net Fluid Balance

  Day 1, Day 2, and Day 3 of hospitalization

• Incidence of Acute Kidney Injury (AKI) Based on KDIGO Criteria

  From admission (Day 1) through hospital discharge (up to 14 days)

Study Arms (2)

Dapagliflozin + Diuretic (Intervention Group)

EXPERIMENTAL

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

Drug: Dapagliflozin (DAPA); Drug: Diuretic

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

Drug: Diuretic

Interventions

Dapagliflozin (DAPA) DRUG

Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy

Dapagliflozin + Diuretic (Intervention Group)

Diuretic DRUG

Arm B (Control Group): Receives standard intravenous diuretic therapy alone

Active Comparator; Dapagliflozin + Diuretic (Intervention Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Type 1 diabetes mellitus
• Urinary tract or genital infection
• Hypovolemia
• Diabetic ketoacidosis
• Serum glucose \< 80 mg/dL at enrollment
• Systolic blood pressure \< 90 mmHg at enrollment
• History of hypersensitivity to any SGLT2 inhibitor
• Pregnant or breastfeeding women
• Severe primary valvular lesion requiring intervention
• Severe hepatic impairment (Child-Pugh class C)
• Estimated glomerular filtration rate \< 25 mL/min/1.73 m² (by MDRD equation)

Sponsors & Collaborators

• May Mohamed Abdalla: lead
• Cairo University: collaborator

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

dapagliflozin; Diuretics

Intervention Hierarchy (Ancestors)

Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

May M Abdalla, Senior teaching assistant

CONTACT

002 01002662985; mayezzeldin@miuegypt.edu.eg

Ahmed M Kamal, Lecturer of Cardiovascular

CONTACT

002 01001284924; dr.ahmedkamal10@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind randomized controlled trial. Neither the participants nor the investigators (including care providers and outcome assessors) are aware of the treatment assignments. This masking minimizes bias in treatment administration, patient perception, and outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior teaching assistant

Model Details: Participants are randomly assigned to one of two groups in parallel for the duration of the study. Arm A: Receives dapagliflozin (10 mg daily) + standard diuretic therapy Arm B: Receives standard diuretic therapy alone Each group is treated simultaneously, and outcomes are compared between the two groups.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

EG (1)