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

  • STATUS
    Recruiting
  • End date
    Jan 5, 2023
  • participants needed
    100
  • sponsor
    Mansoura University
Updated on 19 June 2022

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 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.

Description

Dapagliflozin has been shown to reduce the cardiovascular death and worsening HF in patients with reduced ejection fraction and is likely to be incorporated as a part of guideline-directed medical therapy in patients with established chronic heart failure, either with or without diabetes. Based on both the promising pharmacological and safety profile of dapagliflozin we hypothesized that it might exerts positive effects during hospitalization with acute HF when compared to structured usual care. Clinical evidence from randomized trials in AHF hospitalized patient are so far lacking. The aim of present study is to investigate the efficacy and safety of early initiation of dapagliflozin in those patients.

Details
Condition Acute Decompensated Heart Failure
Treatment Placebo, Dapagliflozin 10Mg Tab
Clinical Study IdentifierNCT05406505
SponsorMansoura University
Last Modified on19 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults aged 18 years or older who are hospitalized for hypervolemic AHF, with evidence of congestion defined as either
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 Criteria

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%
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