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

Sponsor
Cairo University
Study ID
NCT06012279
Phase
PHASE4
Status
Completed

Conditions

  • Acute Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin is a drug that works through inhibition of sodium glucose transporter-2 resulting in glucosuria.

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Feb 2024
Primary completion
Feb 1, 2024
Completion
Feb 26, 2024

Study Design

Enrollment
117 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin group
    This group will receive oral Dapagliflozin 10 mg once daily within 24 hours from hospital admission, in addition to the standard treatment for acute heart failure.
  • No Intervention: Standard group
    This group will only receive the standard treatment for acute heart failure.

Primary Outcome Measure

All-cause mortality during hospitalization. [ Time Frame: From the date of admission until the date of discharge, average of 7 days ]

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