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NCT03030235 · ClinicalTrials.gov registry record · Phase 4
Dapagliflozin in PRESERVED Ejection Fraction Heart Failure
A Phase 4 study of Chronic Heart Failure With Preserved Systolic Function, sponsored by Saint Luke's Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 324
- Enrollment target
- 20
- Study locations
NCT03030235: Completed Phase 4 study of Chronic Heart Failure With Preserved Systolic Function, sponsored by Saint Luke's Health System.
NCT03030235 is a Phase 4 study of Chronic Heart Failure With Preserved Systolic Function that has completed, run by Saint Luke's Health System. The registered enrollment target is 324 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03030235, a Phase 4 study of Chronic Heart Failure With Preserved Systolic Function, has completed, sponsored by Saint Luke's Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 324 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CS) at Week 12. The KCCQ is a disease-specific health status instrument composed of 23 items that quantifies the domains of physical limitations, symptoms, self-efficacy, social limitation and quality of life from heart failure. Scores range from 0-100, in which higher scores reflect better health status. For the KCCQ-CS, a small but clinically meaningful change is considered to be ≥ 5 points. Values have been adjusted for t
Conditions Studied
Interventions
- DRUG Dapagliflozin 10Mg Oral Tablet
- DRUG Dapagliflozin matching placebo
Study Locations (20)
Illinois
- NorthShore University HealthSystem Research Insititute - Evanston
- Northwestern University - Evanston
- Chicago Medical Research - Hazel Crest
- OSF HealthCare Cardiovascular Institute - Peoria
Florida
- First Coast Cardiovascular Institute - Jacksonville
- Charlotte Heart Group Research Center - Port Charlotte
Missouri
- Saint Luke's Mid America Heart Institute - Kansas City
- Washington University - St Louis
New York
- Columbia University - New York
- St. Francis Hospital - New York
North Carolina
- Eastern Nephrology Associates - New Bern
- Wake Forest University - Winston-Salem
Alabama
- Heart Group of the Eastern Shore - Fairhope
California
- University of Southern California - Los Angeles
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2017-03-01 |
| Est. Completion | 2021-08-13 |
| Phase | Phase 4 |
What the finished NCT03030235 record still lists
NCT03030235 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (37% lower).
The record links to 1 condition, with Chronic Heart Failure With Preserved Systolic Function appearing as the primary indexed condition, and to 2 interventions - of which Dapagliflozin 10Mg Oral Tablet is the first listed.
NCT03030235 names 20 study sites across 13 states, led by Illinois, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT03030235 about?
NCT03030235 is a clinical study titled "Dapagliflozin in PRESERVED Ejection Fraction Heart Failure". 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.
What is the current status of trial NCT03030235?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 324 participants. The study started on 2017-03-01. Estimated completion is 2021-08-13.
What conditions does trial NCT03030235 study?
This clinical trial studies the following conditions: Chronic Heart Failure With Preserved Systolic Function.
What interventions are being tested in trial NCT03030235?
The interventions under investigation include: Dapagliflozin 10Mg Oral Tablet (DRUG), Dapagliflozin matching placebo (DRUG).
Who is sponsoring clinical trial NCT03030235?
This trial is sponsored by Saint Luke's Health System, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03030235 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03030235's enrollment target sits among peer trials
324 254th of 2000 higher than 1,747 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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