The Effect of Dapagliflozin on Patients With Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMay Mohamed Abdalla
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Type 1 diabetes mellitus
Urinary tract or genital infection
Hypovolemia
Diabetic ketoacidosis
Trial design
Design model
Parallel
Treatments tested in this trial
Dapagliflozin (DAPA)
DrugReceives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy
Diuretic
DrugArm B (Control Group): Receives standard intravenous diuretic therapy alone
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Dapagliflozin + Diuretic (Intervention Group)Experimental treatment 2 interventions
Group B: Active ComparatorActive comparator 1 intervention
Trial outcomes
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.
Time frame
Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission)Secondary outcomes
1
Effect of Dapagliflozin on Hospital Length of Stay
To assess the effect of dapagliflozin on the duration of hospitalization, measured in total days from admission to discharge.
Time frame
From hospital admission to hospital discharge (an average of 7 days)2
Effect of Dapagliflozin on Renal Biomarker NGAL
To assess the effect of dapagliflozin on renal injury using the neutrophil gelatinase-associated lipocalin (NGAL) level in ng/mL as a renal biomarker.
Time frame
Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)3
Change in NT-proBNP Levels
To assess the change in NT-proBNP levels (pg/mL) in patients receiving dapagliflozin during hospitalization for acute heart failure.
Time frame
Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)4
Change in Net Fluid Balance
To determine the net fluid balance (fluid input minus output) (mL per 24 hours) to evaluate diuretic efficiency in patients receiving dapagliflozin.
Time frame
Day 1, Day 2, and Day 3 of hospitalizationSponsors and contacts
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Source ClinicalTrials.gov