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 — DRUGpatients will receive once daily dapagliflozin 10 mg orally in addition to standard care
- Placebo — OTHERpatients 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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