Status:
COMPLETED
Efficacy and Safety of Dapagliflozin in Acute Heart Failure
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
AstraZeneca
Conditions:
Heart Failure
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 follo...
Detailed Description
Patients with acute decompensated HF (ADHF) are generally admitted due to symptoms of congestion and 90% are treated with a loop diuretic. However at least one-third of these patients are inadequately...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04298229
Start Date
April 1 2020
End Date
May 17 2023
Last Update
March 15 2024
Active Locations (6)
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1
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27514
3
INTEGRIS
Oklahoma City, Oklahoma, United States, 73112
4
TriStar Centennial Medical Center
Nashville, Tennessee, United States, 37203