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NCT03988634 · ClinicalTrials.gov registry record · Phase 3
Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)
A Phase 3 study of Heart Failure With Preserved Ejection Fraction (HFPEF), sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 467
- Enrollment target
- 20
- Study locations
NCT03988634: Completed Phase 3 study of Heart Failure With Preserved Ejection Fraction (HFPEF), sponsored by Novartis Pharmaceuticals.
NCT03988634 is a Phase 3 study of Heart Failure With Preserved Ejection Fraction (HFPEF) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 467 participants, above the 168-participant average among 9 other Heart Failure With Preserved Ejection Fraction (HFPEF) trials with a reported enrollment target (178% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03988634, a Phase 3 study of Heart Failure With Preserved Ejection Fraction (HFPEF), has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 467 participants
- Enrollment target
- 20
- Study locations
Study Summary
The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days post-decompensation.
Primary Outcome
To demonstrate the effect of sacubitril/valsartan vs. valsartan on time-averaged proportional change in N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to weeks 4 and 8 in heart failure with preserved ejection fraction (HFpEF) patients with a worsening heart failure event (HFpEF decompensation) who have been stabilized for and initiated at the time of or within 30 days post-decompensation. Plasma NT-proBNP (pg/mL) values were averaged from Week 4 and Week 8 visits. The change
Conditions Studied
Interventions
- DRUG sacubitril/valsartan
- DRUG valsartan
- DRUG sacubitril/valsartan matching placebo
- DRUG valsartan matching placebo
Study Locations (20)
California
- University of Calif Irvine Med Cntr - Irvine
- Memorial Care Health System Memorialcare Long Beach - Long Beach
- University Of Southern California . - Los Angeles
- University Of Southern California - Los Angeles
- San Diego Cardiac Center - San Diego
- Zuckerberg General W84 Research . - San Francisco
- Sutter Health Network . - San Pablo
- Helping Hands Medical Associates INC - Santa Ana
Florida
- University of Florida Health . - Gainesville
- New Generation of Medical Research Avera Health N Central Heart - Hialeah
- University of Florida Health Science Center - Jacksonville
- Intercoastal Medical Group - Sarasota
Colorado
- St Francis Medical Center - Colorado Springs
- Colorado Heart and Vascular . - Lakewood
- South Denver Cardiology Associates PC - Littleton
Connecticut
- Hartford Healthcare Headache Center - West Hartford
- VA Connecticut Healthcare System - West Haven
Georgia
- Morehouse School Of Medicine - Atlanta
- Emory University School of Medicine/Winship Cancer Institute - Atlanta
Delaware
- Cardiology Physicians PA . - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2019-06-29 |
| Est. Completion | 2022-12-14 |
| Phase | Phase 3 |
What the finished NCT03988634 record still lists
NCT03988634 is an interventional study that assigns participants to a tested intervention. The registered 467 participants enrollment target is mid-sized for trials with a published cap, above the 168-participant average among 9 other Heart Failure With Preserved Ejection Fraction (HFPEF) trials with a reported enrollment target (178% higher).
The record links to 1 condition, with Heart Failure With Preserved Ejection Fraction (HFPEF) appearing as the primary indexed condition, and to 4 interventions - of which sacubitril/valsartan is the first listed.
NCT03988634 names 20 study sites across 6 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT03988634 about?
NCT03988634 is a clinical study titled "Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)". The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days post-decompensation.
What is the current status of trial NCT03988634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 467 participants. The study started on 2019-06-29. Estimated completion is 2022-12-14.
What conditions does trial NCT03988634 study?
This clinical trial studies the following conditions: Heart Failure With Preserved Ejection Fraction (HFPEF).
What interventions are being tested in trial NCT03988634?
The interventions under investigation include: sacubitril/valsartan (DRUG), valsartan (DRUG), sacubitril/valsartan matching placebo (DRUG), valsartan matching placebo (DRUG).
Who is sponsoring clinical trial NCT03988634?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03988634 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure With Preserved Ejection Fraction (HFPEF)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03988634's enrollment target sits among peer trials
467 2nd of 9 the highest of 9 other Heart Failure With Preserved Ejection Fraction (HFPEF) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure With Preserved Ejection Fraction (HFPEF) 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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