Using sildenafil to improve blood vessel health in patients with heart pumps
Official title: Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
Run by Montefiore Medical Center · NCT06510322 · Data updated 2026-11-12
This study is testing if the medication sildenafil can help improve blood vessel health and reduce complications in patients using heart pumps.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | March 12, 2025 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | January 23, 2026 |
| Trial ID | NCT06510322 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who are currently supported by or are planning to undergo placement of a durable LVAD.
✕Probably not a fit
Patients with a history of aortic valve prosthesis, allergies to sildenafil, or those taking nitric oxide donor medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of sildenafil, a medication known for its anti-fibrotic properties, on vascular remodeling in patients supported by left ventricular assist devices (LVADs). The research aims to determine if sildenafil can reduce the adverse vascular events that commonly occur in these patients, such as stroke and bleeding. Participants will be randomly assigned to receive either sildenafil or a placebo, and their small blood vessels will be assessed using video capsule endoscopy. The study focuses on understanding how sildenafil impacts vascular health during LVAD support.
Why it matters
Potential benefit: If successful, this study could lead to improved vascular health and reduced complications for patients with LVADs.
How similar studies have gone: While the use of sildenafil in this context is novel, similar studies have shown promise in using PDE5 inhibitors for vascular health.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Over 18 years of age * Supported by a durable LVAD or planned to undergo placement of a durable LVAD * Be able to give informed consent Exclusion Criteria: * History of pre-existing aortic valve prosthesis or an aortic graft * Allergy to sildenafil * Taking any nitric oxide (NO) donor medications * History of complete carotid occlusion
Where it's running
-
Montefiore Medical Center
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Omar Saeed, MD — Montefiore Medical Center
- Study coordinator: Omar Saeed, MD
- Email: osaeed@montefiore.org
- Phone: 718-920-2626
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.