The Effect of Dapagliflozin on Patients With Cardiomyopathy

May Mohamed Abdalla

Status and phase: Enrolling; Phase 4

Conditions: Acute Decompensated Heart Failure (ADHF)

Treatments: Drug: Diuretic; Drug: Dapagliflozin (DAPA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07076615

N-73-2024

PO.3.4.1 (Other Identifier)

Details and patient eligibility

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

Full description

Acute Heart Failure (AHF) is a life-threatening syndrome and a leading cause of hospitalization worldwide. Effective decongestion during AHF episodes is essential for improving patient outcomes and reducing hospital readmissions. Sodium-glucose co-transporter 2 (SGLT2) inhibitors, particularly dapagliflozin, have shown significant promise in improving cardiovascular outcomes in chronic heart failure; however, their role during acute episodes remains under active investigation.

This prospective, randomized controlled trial aims to assess the efficacy and safety of early dapagliflozin initiation in hospitalized adult patients with AHF, irrespective of diabetes status. A total of 100 patients admitted to the Cardiology and Intensive Care Departments of Kasr Al Ainy Hospital, Cairo University, will be enrolled and randomized (1:1) to either standard diuretic therapy alone or dapagliflozin (10 mg once daily) plus diuretics.

The study's primary endpoint is the degree of pulmonary congestion, evaluated through lung ultrasound (LUS) using an 8-zone scanning protocol and quantification of B-lines. Secondary outcomes include hospital length of stay, diuretic response, changes in cardiac biomarkers (NT-proBNP, sST2, and CA-125), renal biomarker NGAL, and incidence of acute kidney injury.

LUS and echocardiography will be performed by certified intensivists using standardized protocols. Biomarkers will be measured via ELISA kits at three time points: within 24 hours of admission, and at discharge.

The hypothesis is that early use of dapagliflozin in AHF enhances decongestion, improves natriuretic response, and enables earlier hospital discharge without increasing adverse renal or metabolic events.

The results of this study will provide valuable insights into the use of SGLT2 inhibitors during the acute phase of heart failure and may inform future clinical practice guidelines.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Dapagliflozin + Diuretic (Intervention Group)

Experimental group

Description:

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

Treatment:

Drug: Dapagliflozin (DAPA)

Drug: Diuretic

Active Comparator

Active Comparator group

Description:

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

Treatment:

Drug: Diuretic