RecruitingEarly Phase 1NCT06510322

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support


Sponsor

Montefiore Medical Center

Enrollment

50 participants

Start Date

Mar 12, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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

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Interventions

DRUGSildenafil

Orally administered phosphodiesterase-5 (PDE-5) inhibitor, which enhances nitric oxide signaling in platelets and blood vessels.

OTHERPlacebo

Matched capsule not containing any medication


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT06510322


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