NCT06510322 Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
| NCT ID | NCT06510322 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Montefiore Medical Center |
| Condition | Vascular Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2025-03-12 with a primary completion date of 2029-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Omar Saeed, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT06510322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vascular Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06510322 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06510322 currently recruiting?
Yes, NCT06510322 is actively recruiting participants. Contact the research team at osaeed@montefiore.org for enrollment information.
Where is the NCT06510322 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT06510322 clinical trial?
NCT06510322 is sponsored by Montefiore Medical Center. The principal investigator is Omar Saeed, MD at Montefiore Medical Center. The trial plans to enroll 50 participants.