Phase 3
Completed N=240
Efficacy and Safety of Dapagliflozin in Acute Heart Failure
Source: ClinicalTrials.gov NCT04298229 ↗Enrolled (actual)
240
Serious AEs
5.5%
Results posted
Mar 2024
Primary outcomePrimary: Cumulative Change in Weight (Kilograms) Per 40mg of IV Furosemide Equivalents, Adjusted for Baseline Weight — -0.31; -0.42 kg/40mg IV furosemide
◆ Published Evidence
Highly cited
125citations · ~63 / year
Efficacy and Safety of Dapagliflozin in Patients With Acute Heart Failure.
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 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.
Linked Publications (2)
-
Efficacy and Safety of Dapagliflozin in Patients With Acute Heart Failure.
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Interaction of Kidney Function and Dapagliflozin in Patients With Acute Heart Failure: A Pre-Specified Analysis of DICTATE-AHF.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative Change in Weight (Kilograms) Per 40mg of IV Furosemide Equivalents, Adjusted for Baseline Weight |
-0.31; -0.42 | — |
| SECONDARY Number of Participants With Inpatient Worsening Heart Failure |
3; 4 | — |
| SECONDARY Hospital Readmission |
20; 19 | — |
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
Data sourced from ClinicalTrials.gov (NCT04298229) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.