NCT06012279CompletedPhase 4
Clinical Outcomes of Dapagliflozin in Acute Heart Failure With Reduced Ejection Fraction (CODA-HFrEF)
Clinical Outcomes of Dapagliflozin in Acute Heart Failure With Reduced Ejection Fraction, a Randomized Controlled Trial (CODA-HFrEF)
Source: ClinicalTrials.gov · Last updated 28 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 117 (actual)
- First submitted
- 10 Aug 2023
- Start date
- Aug 2023
- Primary completion date
- Feb 2024
- Lead sponsor
- Cairo University
- Diseases
- Heart failure
- NCT number
- NCT06012279
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 117
- From Aug 2023 to the primary completion date, Feb 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with any SGLT2 inhibitor in the last month.
- Known intolerance to any SGLT2 inhibitor.
Other illness
- Type I DM or history of DKA.
Lab values
- Estimated GFR \< 30 mL/min/1.73 m2.
- Severe anemia (Hemoglobin \< 7 g/dl).
Other
- Cardiogenic shock on admission, defined as SBP \< 90 mmHg plus signs of peripheral hypoperfusion or the need of vasopressor or inotropic support.
- Pregnancy or lactation.
Who the study is looking for
- 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%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aswan Heart Centre Coordinator of this site? Confirm its status | Aswān | Egypt | Unknown status |
| Kasr Al-Ainy Medical School Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.