| Trial ID: | L2737 |
| Source ID: | NCT04298229
|
| Associated Drug: |
Dapagliflozin 10 Mg
|
| Title: |
Efficacy and Safety of Dapagliflozin in Acute Heart Failure
|
| Acronym: |
DICTATE-AHF
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04298229/results
|
| Conditions: |
Heart Failure|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Dapagliflozin 10 MG|OTHER: Protocolized Diuretic Therapy
|
| Outcome Measures: |
Primary: Cumulative Change in Weight (Kilograms) Per 40mg of IV Furosemide Equivalents, Adjusted for Baseline Weight, cumulative change in weight (kilograms) per 40mg of IV furosemide equivalents from enrollment to day 5 or discharge (if earlier) between protocolized diuretic therapy and dapagliflozin plus protocolized diuretic therapy guided by urine output, Baseline to Day 5 or discharge if earlier | Secondary: Number of Participants With Inpatient Worsening Heart Failure, Number of participants with worsening heart failure during hospitalization requiring IV inotropic therapy with dobutamine, milrinone, or dopamine or admission to an intensive care unit as adjudicated by the Clinical Event Adjudication Committee, Baseline to hospital discharge, an average of 5 days|Hospital Readmission, Hospital readmission within 30 days of discharge for heart failure or diabetic reasons as adjudicated by the Clinical Event Adjudication Committee, Day 30
|
| Sponsor/Collaborators: |
Sponsor: Vanderbilt University Medical Center | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
240
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2020-04-01
|
| Completion Date: |
2023-05-17
|
| Results First Posted: |
2024-03-15
|
| Last Update Posted: |
2024-03-15
|
| Locations: |
University of Mississippi Medical Center, Jackson, Mississippi, 39216, United States|University of North Carolina, Chapel Hill, North Carolina, 27514, United States|INTEGRIS, Oklahoma City, Oklahoma, 73112, United States|TriStar Centennial Medical Center, Nashville, Tennessee, 37203, United States|Saint Thomas West Hospital, Nashville, Tennessee, 37205, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04298229
|
