Status:
COMPLETED
Effect of Dapagliflozin in Patients With Acute Heart Failure (DAPA-RESPONSE-AHF)
Lead Sponsor:
Mansoura University
Conditions:
Acute Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 angi...
Eligibility Criteria
Inclusion
- Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either:
- \* 2 of the following signs or symptoms: peripheral edema, ascites, jugular venous pressure \> 10mmHg, orthopnea, paroxysmal nocturnal dyspnea, 5-pound weight gain, or signs of congestion on chest x-ray or lung ultrasound.
- OR
- \*If pulmonary artery catheterization is available, a pulmonary capillary wedge pressure greater than 19 mmHg plus a systemic physical exam finding of hypervolemia from the list above.
- Randomized within 24 hours of hospitalization for AHF
- Planned use of IV loop diuretic therapy during current hospitalization
- Estimated glomerular filtration rate (eGFR) of at least 30 ml/min/1.73m2 by the MDRD equation
- For diabetic patients, history of type 2 diabetes or a new hemoglobin A1c 6.5% on admission.
Exclusion
- Type 1 diabetes mellitus.
- Dyspnea primarily due to non-cardiac causes.
- Cardiogenic shock.
- Acute coronary syndrome within 30 days prior to randomization.
- Planned or recent percutaneous or surgical coronary intervention within 30 days prior to randomization.
- Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH\>7.30 and glucose \>15 mmol/L and HCO3\>18 mmol/L).
- Pregnant or nursing (lactating) women.
- Heart failure due to drug toxicity
- Adherence to medication less than 95%
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT05406505
Start Date
April 25 2022
End Date
July 1 2023
Last Update
August 4 2023
Active Locations (1)
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1
Noha Mansour
Al Mansurah, Egypt, 35516