Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)

Sponsor
Mansoura University
Study ID
NCT05406505
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Acute Heart Failure

Eligibility Criteria

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

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    patients will receive once daily dapagliflozin 10 mg orally in addition to standard care
  • Placebo — OTHER
    patients will receive placebo and standard care.

Study Details

Dapagliflozin, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), increases natriuresis alone and synergistically when combined with loop diuretics in patients with AHF without increasing renin angiotensin- aldosterone activity. Thus, adding SGLT2i to the standard loop diuretic therapy might confer additional decongestive and natriuretic benefits while avoiding the adverse electrolyte abnormalities and neurohormonal activation associated with other diuretic combination. These potential benefits may help with improved clinical outcomes, but clinical evidence is still lacking.

Key Dates

Start date
Apr 25, 2022
Status verified
Aug 2023
Primary completion
May 1, 2023
Completion
Jul 1, 2023

Study Design

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

Arms

  • Experimental: Dapagliflozine 10mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in dyspnea ( Visual analogue scale) (VAS) [ Time Frame: From baseline to day 4 ]

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