The Effect of Dapagliflozin on Patients With Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin (DAPA), Diuretic.
- Who it may be relevant to
- Registry conditions: Acute Decompensated Heart Failure (ADHF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Dapagliflozin (DAPA)
Receives dapagliflozin 10 mg once daily + standard intravenous diuretic therapy - Drug Diuretic
Arm B (Control Group): Receives standard intravenous diuretic therapy alone
Primary outcome measures
- Effect of Dapagliflozin on Pulmonary Congestion Assessed by Lung Ultrasound (LUS) [Time frame: Day 1 (Baseline) Day 3 within 24 hours prior to hospital discharge (mean 7 days post-admission)]
Secondary outcome measures (7)
- Effect of Dapagliflozin on Hospital Length of Stay [Time frame: From hospital admission to hospital discharge (an average of 7 days)]
- Effect of Dapagliflozin on Renal Biomarker NGAL [Time frame: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)]
- Change in NT-proBNP Levels [Time frame: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)]
- Change in Net Fluid Balance [Time frame: Day 1, Day 2, and Day 3 of hospitalization]
- Incidence of Acute Kidney Injury (AKI) Based on KDIGO Criteria [Time frame: From admission (Day 1) through hospital discharge (up to 14 days)]
- Change in sST2 Levels [Time frame: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)]
- Change in CA-125 Levels [Time frame: Baseline (within 24 hours of admission), and within 24 hours prior to hospital discharge (mean 7 days)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07076615 · N-73-2024 · PO.3.4.1