RECRUITING

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Quick Facts

Study Start:2025-02
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06510322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Over 18 years of age
  2. * Supported by a durable LVAD or planned to undergo placement of a durable LVAD
  3. * Be able to give informed consent
  1. * History of pre-existing aortic valve prosthesis or an aortic graft
  2. * Allergy to sildenafil
  3. * Taking any nitric oxide (NO) donor medications
  4. * History of complete carotid occlusion

Contacts and Locations

Study Contact

Omar Saeed, MD
CONTACT
718-920-2626
osaeed@montefiore.org
Lorenzo D'Angelo, MD
CONTACT
718-920-2626

Principal Investigator

Omar Saeed, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10461
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • Omar Saeed, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2029-12

Study Record Updates

Study Start Date2025-02
Study Completion Date2029-12

Terms related to this study

Additional Relevant MeSH Terms

  • Vascular Diseases