Dapagliflozin at Discharge on Hospital Heart Failure Readmission

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04249778
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Participants will receive 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.
  • Placebo — DRUG
    Participants will receive a placebo to match 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.

Study Details

This study will evaluate the safety and efficacy of dapagliflozin treatment in preventing hospital re-admissions, emergency room (ER) visits, urgent clinic visits, and death in patients with and without type 2 diabetes (T2D) after hospital admission for heart failure.

Key Dates

Start date
Jul 29, 2020
Status verified
May 2024
Primary completion
Mar 3, 2022
Completion
Mar 3, 2022

Study Design

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

Arms

  • Experimental: Dapagliflozin
    Patients admitted with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive 10 mg of dapagliflozin, once daily for 26 weeks.
  • Placebo Comparator: Placebo
    Patients admitted with exacerbation of chronic heart failure by clinical and radiologic features randomized to receive a placebo to match 10 mg of dapagliflozin, once daily for 26 weeks.

Primary Outcome Measure

Number of Participants With Hospital Admissions, Emergency Department Visits, Urgent Clinic Visits, and Death [ Time Frame: Up to 26 weeks ]

Locations (3)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322-
Tulane UniversityNew OrleansLouisiana70118-
Temple UniversityPhiladelphiaPennsylvania19122-

Find similar trials in Atlanta, GA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Emory University Hospital· Atlanta, GATulane University· New Orleans, LATemple University· Philadelphia, PA

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