RecruitingEarly Phase 1

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

United States50 participantsStarted 2025-03-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change in Aortic Pulse Wave Velocity

Timeframe: From Baseline to 180 days

Change in Gastrointestinal Angiodysplasia (GIAD) Foci

Timeframe: From Baseline to 180 days

Change in Vascular Reactivity Index

Timeframe: From Baseline to 180 days

Trial details

NCT IDNCT06510322

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Omar Saeed, MD

718-920-2626 osaeed@montefiore.org

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