Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

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.

Conditions

Vascular Diseases

Study Overview

Study Details

Study overview

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.

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Condition
Vascular Diseases
Intervention / Treatment

-

Contacts and Locations

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10461

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Montefiore Medical Center,

Omar Saeed, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

2029-12