Efficacy and Safety of Dapagliflozin in Acute Heart Failure
Completed · Phase 3
Conditions studied: Heart Failure, Diabetes Mellitus, Type 2
In brief
This is a randomized trial of the addition of dapagliflozin to patients with or without type 2 diabetes hospitalized with acute decompensated heart failure (ADHF). Participants will be recruited following an initial standard evaluation in the ED and randomized within 24 hours of presentation for ADHF in a 1:1 fashion to protocolized diuretic therapy or dapagliflozin + protocolized diuretic therapy.
Key facts
- Study ID
- NCT04298229
- Run by
- Vanderbilt University Medical Center
- People needed
- 240
- Starts
- 2020-04-01
- Expected to finish
- 2023-05-17
- Last updated by the study team
- 2024-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age of 18 years or older
- Randomized within 24 of presentation during a hospital admission for hypervolemic decompensated heart failure defined as:
- pulmonary artery catheterization with a pulmonary capillary wedge pressure greater than 19mmHg plus a systemic physical exam finding of hypervolemia (peripheral edema, ascites, or pulmonary edema on auscultation)
- in the absence of pulmonary artery catheterization data 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
- Planned use of IV loop diuretic therapy during current hospitalization
- eGFR of 25 ml/min/1.73m2 by the MDRD equation or greater
You may not qualify if…
- Type 1 diabetes
- Serum glucose < 80mg/dl at enrollment
- Systolic blood pressure < 90mmHg at enrollment
- Requirement of intravenous inotropic therapy or anticipated need during the study
- History of hypersensitivity to any SGLT2 inhibitors
- Women who are pregnant or breastfeeding
- Severe anemia (Hemoglobin < 7.5g/dl)
- Severe uncorrected aortic or mitral stenosis
- Inability to perform standing weights or measure urine output accurately
- History of diabetic ketoacidosis
- Scheduled combination nephron blockade with loop and thiazide therapy as an outpatient for more than 7 days prior to admission (excluding HCTZ < 50mg for blood pressure)
- Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 40-pounds
- Severe hepatic impairment (Child-Pugh class C)
- Clinical picture consistent with acute myocardial infarction including troponin rise and fall or ischemic changes on electrocardiogram
- Site investigator determines the subject is not a good candidate to participate in the study at this tine
Where it is running
- University of Mississippi Medical Center — Jackson, Mississippi, United States
- University of North Carolina — Chapel Hill, North Carolina, United States
- INTEGRIS — Oklahoma City, Oklahoma, United States
- TriStar Centennial Medical Center — Nashville, Tennessee, United States
- Saint Thomas West Hospital — Nashville, Tennessee, United States
- Vanderbilt University Medical Center — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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