Using sildenafil to improve blood vessel health in patients with heart pumps
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06510322 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While the use of sildenafil in this context is novel, similar studies have shown promise in using PDE5 inhibitors for vascular health.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.