Clinical Outcomes of Dapagliflozin in Acute Heart Failure With Reduced Ejection Fraction (CODA-HFrEF)

• Status: Completed
• Trial end date: 2024-02-26
• Target enrollment: 0
• Participant gender: All

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) with reduced ejection fraction.

The main questions it aims to answer are:

• Does early initiation of Dapagliflozin improve the length of hospital stay and in-hospital mortality in patients with ADHF?

• Does early initiation of Dapagliflozin enhance the diuretic response, weight reduction and pro-BNP reduction in the acute stage of HF?

• Does early initiation of Dapagliflozin adversely affect the hemodynamic stability and kidney functions in the acute stage of HF?

Participants will be randomized with the ratio of 1:1 within 24 hours of admission to receive Dapagliflozin 10 mg/day versus standard of care. Follow up will continue for 2 months after hospital discharge.

Researchers will compare the in-hospital and 60-day clinical outcomes in the Dapagliflozin group versus the standard treatment group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Collaborator: Aswan Heart Centre
• Treatments: Dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

1. Cardiogenic shock on admission, defined as SBP < 90 mmHg plus signs of peripheral hypoperfusion or the need of vasopressor or inotropic support.

2. Estimated GFR < 30 mL/min/1.73 m2.

3. Pregnancy or lactation.

4. Type I DM or history of DKA.

5. Treatment with any SGLT2 inhibitor in the last month.

6. Known intolerance to any SGLT2 inhibitor.

7. Severe anemia (Hemoglobin < 7 g/dl).