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Efficacy and Safety of Dapagliflozin in Acute Heart Failure

CompletedPhase 3

Sponsor: Vanderbilt University Medical Center

Conditions: Heart Failure, Diabetes Mellitus, Type 2

Interventions: Dapagliflozin 10 MG, Protocolized Diuretic Therapy

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (6)

Jackson, Mississippi, United States
Chapel Hill, North Carolina, United States
Oklahoma City, Oklahoma, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States