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RECRUITING
NCT06510322
EARLY_PHASE1

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Sponsor: Montefiore Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-03-12

Completion Date

2029-12

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DRUG

Sildenafil

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

OTHER

Placebo

Matched capsule not containing any medication

Locations (1)

Montefiore Medical Center

The Bronx, New York, United States