The Effect of Dapagliflozin on Patients With Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-05-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Acute Decompensated Heart Failure (ADHF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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

Group Type EXPERIMENTAL

Dapagliflozin (DAPA)

Intervention Type DRUG

Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy

Diuretic

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Diuretic

Intervention Type DRUG

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

Interventions

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Dapagliflozin (DAPA)

Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy

Intervention Type DRUG

Diuretic

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No