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

NCT06012279 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

  • Acute Heart Failure

Interventions

DRUG

Dapagliflozin 10mg Tab

Dapagliflozin is a drug that works through inhibition of sodium glucose transporter-2 resulting in glucosuria.

Sponsors & Collaborators

  • Aswan Heart Centre

    collaborator OTHER

  • Cairo University

    lead OTHER

Principal Investigators

  • Magdy Abdelhamid, Professor · Chairman of Cardiology Department, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-02-01
Completion
2024-02-26

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06012279 on ClinicalTrials.gov