Efficacy and Safety of Dapagliflozin in Acute Heart Failure

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized trial of the addition of dapagliflozin to patients with 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: AstraZeneca
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin; Diuretics; Sodium-Glucose Transporter 2 Inhibitors

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 > 30 ml/min/1.73m2 by the MDRD equation

• History of type 2 diabetes or a new hemoglobin A1c > 6.5% this admission

Exclusion Criteria:

• Type 1 diabetes

• Serum glucose < 80mg/dl at enrollment

• Systolic blood pressure < 90mmHg at enrollment

• Requirement of intravenous inotropic therapy

• 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

• Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 40-pounds

• Severe hepatic impairment (Child-Pugh class C)