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NCT06510322 · ClinicalTrials.gov registry record · Early Phase 1
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
A Early Phase 1 study of Vascular Diseases, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06510322: Recruiting Early Phase 1 study of Vascular Diseases, sponsored by Montefiore Medical Center.
NCT06510322 is a Early Phase 1 study of Vascular Diseases that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 50 participants, below the 560-participant average among 40 other Vascular Diseases trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06510322, a Early Phase 1 study of Vascular Diseases, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Contemporary left ventricular assist device (LVAD) therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and bleeding in nearly half of patients. In this study, the study team aims to investigate whether sildenafil pharmacotherapy, which has anti-fibrotic effects, can reduce vascular aging during LVAD support. An aim of this study is to compare changes in small blood vessels in the gastrointestinal tract between participants receiving sildenafil or placebo. Video capsule endoscopy (VCE) will be used to assess these changes in small blood vessels.
Primary Outcome
Pulse wave velocity (PWV) will be measured by vascular ultrasound. PWV will be calculated by dividing the distance between the carotid and femoral artery waveform acquisition sites (in meters) by the carotid-femoral transit time (change in time, in seconds). Change in group mean PWV from baseline will be summarized. Increases in PWV can be an indicator of vascular fibrosis and are associated with increased risk of cardiovascular comorbidities.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Sildenafil
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-03-12 |
| Est. Completion | 2029-12 |
| Phase | Early Phase 1 |
What NCT06510322 shows while recruiting
NCT06510322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 560-participant average among 40 other Vascular Diseases trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Vascular Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06510322 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06510322 about?
NCT06510322 is a clinical study titled "Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support". Contemporary left ventricular assist device (LVAD) therapy improves survival during advanced heart failure but vascular aging develops rapidly leading to major adverse events including stroke and bleeding in nearly half of patients. In this study, the study team aims to investigate whether sildenafi...
What is the current status of trial NCT06510322?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2025-03-12. Estimated completion is 2029-12.
What conditions does trial NCT06510322 study?
This clinical trial studies the following conditions: Vascular Diseases.
What interventions are being tested in trial NCT06510322?
The interventions under investigation include: Placebo (OTHER), Sildenafil (DRUG).
Who is sponsoring clinical trial NCT06510322?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06510322 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vascular Diseases
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 NCT06510322's enrollment target sits among peer trials
50 34th of 40 higher than 5 of 40 other Vascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vascular Diseases 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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