Actively Recruiting
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
Led by Montefiore Medical Center · Updated on 2026-01-23
50
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
M
Montefiore Medical Center
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
Research Team
O
Omar Saeed, MD
CONTACT
L
Lorenzo D'Angelo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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