Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
Omar Saeed, MD
osaeed@montefiore.org
718-920-2626
Backup
Lorenzo D'Angelo, MD
718-920-2626
Time Frame
Start Date: 2025-03-12
Estimated Completion Date: 2029-12
Participants
Target number of participants: 50
Treatments
Active_comparator: Sildeanfil
Participants in this arm will receive sildenafil 20mg every 8 hours for 1 week and then dose will be up titrated to 40mg every 8 hours for the duration of the study period.
Placebo_comparator: Placebo
Participants in this arm will receive matching placebo, which serves as a negative control to understand changes in small and large blood vessels.
Related Therapeutic Areas
Sponsors
Leads: Montefiore Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov