Dapagliflozin in PRESERVED Ejection Fraction Heart Failure
Part of paid clinical trials in Fairhope, Alabama.
- Sponsor
- Saint Luke's Health System
- Study ID
- NCT03030235
- Phase
- PHASE4
- Status
- Completed
Conditions
- Chronic Heart Failure With Preserved Systolic Function
Eligibility Criteria
- Sex
- ALL
- Age
- 19 Years - 119 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dapagliflozin 10Mg Oral Tablet — DRUGDapagliflozin 10Mg Oral Tablet
- Dapagliflozin matching placebo — DRUGDapagliflozin matching placebo
Study Details
The primary purpose of this study is to evaluate the impact of dapagliflozin, as compared with placebo, on heart failure, disease specific biomarkers, symptoms, health status and quality of life in patients with chronic heart failure with preserved systolic function.
Key Dates
- Start date
- Mar 1, 2017
- Status verified
- Sep 2022
- Primary completion
- Aug 13, 2021
- Completion
- Aug 13, 2021
Study Design
- Enrollment
- 324 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: DapagliflozinDapagliflozin 10 mg oral tablet, once daily, for 12 weeks
- Placebo Comparator: PlaceboDapagliflozin matching placebo oral tablet, once daily, for 12 weeks
Primary Outcome Measure
Effect of Dapagliflozin, as Compared With Placebo, on Heart Failure Related Health Status Using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Summary Score (KCCQ-CS) [ Time Frame: Baseline to Week 12 ]
Locations (26)
Find similar trials in Fairhope, AL
By research site
Heart Group of the Eastern Shore· Fairhope, ALUniversity of Southern California· Los Angeles, CAFirst Coast Cardiovascular Institute· Jacksonville, FLCharlotte Heart Group Research Center· Port Charlotte, FLEmory University· Atlanta, GANorthShore University HealthSystem Research Insititute· Evanston, IL