acute heart failure
Conditions
Brief summary
Time to first occurrence of cardiovascular death or worsening heart failure defined as: 1. Worsening HF during the index admission requiring at least one of the following: a) initiation or re-initiation of inotropic therapy for ≥24 hours b) mechanical circulatory support c) invasive ventilatory support for heart failure d) heart transplantation, Time to first occurrence of cardiovascular death or worsening heart failure defined as: 2. Readmission for worsening heart failure, Time to first occurrence of cardiovascular death or worsening heart failure defined as: 3. Worsening heart failure leading to an urgent visit with administration of intravenous diuretic therapy (e.g., outpatient setting, emergency department) without associated hospital admission
Detailed description
Symptomatic hypotension leading to hospitalization or study drug discontinuation, Worsening renal function that results in at least a doubling of serum creatinine, hospitalization, study drug discontinuation, dialysis, or renal death
Interventions
DRUGDapagliflozin Cipla 10 mg Filmtabletten
DRUGMatching placebo administered orally once daily for 2 months
Sponsors
The Brigham And Women’s Hospital Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of cardiovascular death or worsening heart failure defined as: 1. Worsening HF during the index admission requiring at least one of the following: a) initiation or re-initiation of inotropic therapy for ≥24 hours b) mechanical circulatory support c) invasive ventilatory support for heart failure d) heart transplantation, Time to first occurrence of cardiovascular death or worsening heart failure defined as: 2. Readmission for worsening heart failure, Time to first occurrence of cardiovascular death or worsening heart failure defined as: 3. Worsening heart failure leading to an urgent visit with administration of intravenous diuretic therapy (e.g., outpatient setting, emergency department) without associated hospital admission | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic hypotension leading to hospitalization or study drug discontinuation, Worsening renal function that results in at least a doubling of serum creatinine, hospitalization, study drug discontinuation, dialysis, or renal death | — |
Countries
Czechia, Hungary, Poland
Outcome results
None listed