Efficacy and Safety of Dapagliflozin in Acute Heart Failure

Part of paid clinical trials in Jackson, Mississippi.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT04298229
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10 MG — DRUG
    SGLT2 inhibitors being investigated for its diuretic and natriuretic effects on top of protocolized diuretic therapy.
  • Protocolized Diuretic Therapy — OTHER
    Structured usual care arm with protocolized diuretic therapy based on urine output.

Study Details

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.

Key Dates

Start date
Apr 1, 2020
Status verified
Mar 2024
Primary completion
May 17, 2023
Completion
May 17, 2023

Study Design

Enrollment
240 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Protocolized diuretic therapy
    The patients with diabetes will receive standard of care point of care blood glucose monitoring 4 times daily (before meals and at bedtime) and sliding scale insulin. The initial loop diuretic regimen after enrollment: Loop diuretic naïve: If the patient does not take a scheduled loop diuretic as an outpatient, the initial IV loop diuretic dose will be 40mg of furosemide equivalents every 12 hours. Chronic, oral loop diuretic therapy: If the patient takes a scheduled loop diuretic regimen as an outpatient prior to hospital admission, the initial IV loop diuretic daily dose will be 2 times the total daily home regimen dose. Diuretic therapy will be titrated to goal urine output using a standardized diuretic protocol.
  • Experimental: Protocolized diuretic therapy plus SGLT2 inhibitor therapy
    The patients with diabetes will receive standard of care point of care blood glucose monitoring 4 times daily (before meals and at bedtime) and sliding scale insulin. The initial loop diuretic regimen after enrollment: Loop diuretic naïve: If the patient does not take a scheduled loop diuretic as an outpatient, the initial IV loop diuretic dose will be 40mg of furosemide equivalents every 12 hours. Chronic, oral loop diuretic therapy: If the patient takes a scheduled loop diuretic regimen as an outpatient prior to hospital admission, the initial IV loop diuretic daily dose will be 2 times the total daily home regimen dose. Diuretic therapy will be titrated to goal urine output using a standardized diuretic protocol. The patient will receive SGLT2 inhibitor therapy with dapagliflozin 10 mg orally once daily until 5 days or hospital discharge.

Primary Outcome Measure

Cumulative Change in Weight (Kilograms) Per 40mg of IV Furosemide Equivalents, Adjusted for Baseline Weight [ Time Frame: Baseline to Day 5 or discharge if earlier ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Mississippi Medical CenterJacksonMississippi39216-
University of North CarolinaChapel HillNorth Carolina27514-
INTEGRISOklahoma CityOklahoma73112-
Saint Thomas West HospitalNashvilleTennessee37205-
TriStar Centennial Medical CenterNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-

Find similar trials in Jackson, MS

By condition
Type 2 diabetesHeart failure
By specialty
EndocrinologyMetabolic healthWeight lossCardiologyHeart disease
By research site
University of Mississippi Medical Center· Jackson, MSUniversity of North Carolina· Chapel Hill, NCINTEGRIS· Oklahoma City, OKSaint Thomas West Hospital· Nashville, TNTriStar Centennial Medical Center· Nashville, TNVanderbilt University Medical Center· Nashville, TN

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