Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT06510322

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Montefiore Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

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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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Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support | DecenTrialz