Dapagliflozin at Discharge on Hospital Heart Failure Readmission
Condition: Heart Failure; Diabetes
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will be the first trial to evaluate the safety and efficacy of dapagliflozin
      treatment in preventing readmissions/ER visits/urgent clinic visits, and death in patients
      with and without T2D after admission for heart failure. Treatment with SGLT2-i has been shown
      to reduce both heart failure hospitalizations and mortality in patients with established
      heart disease. However, the time of initiation of SGLT2-i therapy has not been evaluated in
      patients with HF. In addition, the impact of treatment on HF symptoms quality of life,
      resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be
      evaluated. The results of this study have great potential to impact and facilitate care and
      to change current clinical guidelines in the management of patients with heart failure.
    

Detailed description: 
      The prevalence of both heart failure and type 2 diabetes (T2D) or prediabetes are reaching
      epidemic proportions globally and in the United States. More than 40% of patients with
      established heart failure (HF) have diabetes.

      This study will be the first trial to evaluate the safety and efficacy of dapagliflozin
      treatment in preventing hospital re-admissions/ER visits/urgent clinic visits, and death in
      patients with and without T2D after admission for heart failure. Treatment with SGLT2-i has
      been shown to reduce both heart failure hospitalizations and mortality in patients with
      established heart disease. However, the time of initiation of SGLT2-i therapy has not been
      evaluated in patients with HF. In addition, the impact of treatment on HF symptoms quality of
      life, resource utilization, and cost-effectiveness of dapagliflozin versus placebo will be
      evaluated. The results of this study have great potential to impact and facilitate care and
      to change current clinical guidelines in the management of patients with heart failure.

      Patients with and without diabetes who have acute decompensated heart failure (ADHF) will be
      randomized to receive either dapagliflozin (10 mg once daily) or placebo at hospital
      discharge for 26 weeks.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Participants will receive a placebo to match 10 mg/day of dapagliflozin, beginning at hospital discharge, for 26 weeks.
Other intervention name(s): FARXIGA
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hospitalization; mortality; time of initiation of therapy; quality of life; cost-effectiveness; dapagliflozin; clinical trial; diabetes