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NCT03547583 · ClinicalTrials.gov registry record · Phase 2
Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF
A Phase 2 study of Chronic Heart Failure With Preserved Ejection Fraction, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 789
- Enrollment target
- 20
- Study locations
NCT03547583: Completed Phase 2 study of Chronic Heart Failure With Preserved Ejection Fraction, sponsored by Bayer.
NCT03547583 is a Phase 2 study of Chronic Heart Failure With Preserved Ejection Fraction that has completed, run by Bayer. The registered enrollment target is 789 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (493% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03547583, a Phase 2 study of Chronic Heart Failure With Preserved Ejection Fraction, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 789 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.
Primary Outcome
The City Cardiomyopathy Questionnaire (KCCQ) measures the impact of patients' heart failure, or its treatment, on 6 domains; Physical Limitation, Symptom (with subscores for frequency and burden), Quality of Life, Social Limitations, Symptom Stability and Self-Efficacy. Scores are calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets
Study Locations (20)
Florida
- Cardiology Associates Of South Florida PA - Boynton Beach
- Cardiovascular and Vein Center of Florida - Bradenton
- Cardiology Associates Research Company - Daytona Beach
- LifeSpring Research Foundation, LLC - Miami
- Southwest Florida Research - Naples
- East Coast Institute for Research, LLC - Saint Augustine
- Cardiology Partners - Wellington
California
- WestSide Medical - Beverly Hills
- Capitol Interventional Cardiology - Carmichael
- Interventional Cardiology Medical Group - West Hills
Illinois
- Fox Valley Clinical Research Center, LLC - Aurora
- Advocate Condell Medical Center - Libertyville
Colorado
- Penrose-St. Francis Health Services - Colorado Springs
Connecticut
- Cardiology Associates of Fairfield County, PC - Trumbull
Indiana
- Reid Health - Richmond
Kentucky
- Research Integrity, LLC - Owensboro
Louisiana
- Heart Clinic of Hammond - Hammond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 789 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2019-11-04 |
| Phase | Phase 2 |
What the finished NCT03547583 record still lists
NCT03547583 is an interventional study that assigns participants to a tested intervention. The registered 789 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (493% higher).
The record links to 1 condition, with Chronic Heart Failure With Preserved Ejection Fraction appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03547583 names 20 study sites across 11 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT03547583 about?
NCT03547583 is a clinical study titled "Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF". The primary hypothesis in this trial is that the treatment with vericiguat 10 mg or 15 mg in patients with HFpEF improves the KCCQ PLS (Kansas City Cardiomyopathy Questionnaire Physical limitation score) compared to placebo after 24 weeks of treatment.
What is the current status of trial NCT03547583?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 789 participants. The study started on 2018-06-15. Estimated completion is 2019-11-04.
What conditions does trial NCT03547583 study?
This clinical trial studies the following conditions: Chronic Heart Failure With Preserved Ejection Fraction.
What interventions are being tested in trial NCT03547583?
The interventions under investigation include: Placebo (DRUG), Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets (DRUG).
Who is sponsoring clinical trial NCT03547583?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03547583 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, 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 NCT03547583's enrollment target sits among peer trials
789 40th of 2000 higher than 1,961 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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