Status:
COMPLETED
Clinical Outcomes of Dapagliflozin in Acute Heart Failure With Reduced Ejection Fraction (CODA-HFrEF)
Lead Sponsor:
Cairo University
Collaborating Sponsors:
Aswan Heart Centre
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this clinical trial is to evaluate the short-term clinical outcomes of starting Dapagliflozin on the same day of hospital admission in patients with acute decompensated heart failure (ADHF...
Detailed Description
Background and Rationale: With growing interest in studying the pharmacodynamics of SGLT-2 inhibitors, several cardio-protective mechanisms were defined beyond their diuretic effect. Those included a...
Eligibility Criteria
Inclusion
- Adult patients above 18 years presenting with acute heart failure defined as rapid development of dyspnea NYHA class III-IV associated with clinical signs of HF (e.g. congested neck veins, pulmonary rales, lower limb swelling, radiological evidence of pulmonary congestion) with LVEF ≤ 40%.
Exclusion
- Cardiogenic shock on admission, defined as SBP \< 90 mmHg plus signs of peripheral hypoperfusion or the need of vasopressor or inotropic support.
- Estimated GFR \< 30 mL/min/1.73 m2.
- Pregnancy or lactation.
- Type I DM or history of DKA.
- Treatment with any SGLT2 inhibitor in the last month.
- Known intolerance to any SGLT2 inhibitor.
- Severe anemia (Hemoglobin \< 7 g/dl).
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT06012279
Start Date
August 1 2023
End Date
February 26 2024
Last Update
February 28 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Aswan Heart Centre
Aswān, Egypt
2
Kasr Al-Ainy Medical School
Cairo, Egypt, 11562