The Effect of Dapagliflozin on Patients With Cardiomyopathy
- Conditions
- Acute Decompensated Heart Failure (ADHF)
- Interventions
- Drug: Diuretic
- Registration Number
- NCT07076615
- Lead Sponsor
- May Mohamed Abdalla
- 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
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dapagliflozin + Diuretic (Intervention Group) Dapagliflozin (DAPA) 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 Dapagliflozin + Diuretic (Intervention Group) Diuretic 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 Diuretic 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 Measures
Name Time Method Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS) Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission) 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.
- Secondary Outcome Measures
Name Time Method Effect of Dapagliflozin on Renal Biomarker NGAL Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days) To assess the effect of dapagliflozin on renal injury using the neutrophil gelatinase-associated lipocalin (NGAL) level in ng/mL as a renal biomarker.
Change in NT-proBNP Levels Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days) To assess the change in NT-proBNP levels (pg/mL) in patients receiving dapagliflozin during hospitalization for acute heart failure.
Effect of Dapagliflozin on Hospital Length of Stay From hospital admission to hospital discharge (an average of 7 days) To assess the effect of dapagliflozin on the duration of hospitalization, measured in total days from admission to discharge.
Incidence of Acute Kidney Injury (AKI) Based on KDIGO Criteria From admission (Day 1) through hospital discharge (up to 14 days) To determine the incidence of acute kidney injury (AKI) according to KDIGO guidelines in patients receiving dapagliflozin during hospitalization.
Change in Net Fluid Balance Day 1, Day 2, and Day 3 of hospitalization To determine the net fluid balance (fluid input minus output) (mL per 24 hours) to evaluate diuretic efficiency in patients receiving dapagliflozin.
Change in sST2 Levels Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days) To evaluate the effect of dapagliflozin on soluble ST2 (sST2) (ng/mL) concentrations in patients with acute heart failure.
Change in CA-125 Levels Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days) To measure the change in CA-125 (Cancer Antigen 125) levels (U/mL) in patients treated with dapagliflozin during hospitalization for acute heart failure.
Trial Locations
- Locations (1)
Cairo University
🇪🇬Cairo, Egypt
Cairo University🇪🇬Cairo, EgyptAhmed M Kamal, Lecturer of CardiovascularContact002 01001284924dr.ahmedkamal10@gmail.com