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Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

RecruitingEARLY Phase 1Ages 18 Years - anyAllMontefiore Medical Center
NCT06510322 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Sildenafil
  • Placebo
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Where

1 site
Montefiore Medical Center
The Bronx, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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