Recruiting
Early Phase 1

Sildenafil

Sponsor:

Montefiore Medical Center

Code:

NCT06510322

Conditions

Vascular Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sildenafil

Placebo

Study Details

Brief 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.

Conditions

Vascular Diseases

Study ID

NCT06510322

Start date

Mar 12, 2025

Status verified date

Jan, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Sildenafil

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.

Interventions

Sildenafil

Orally administered phosphodiesterase-5 (PDE-5) inhibitor, which enhances nitric oxide signaling in platelets and blood vessels.

Placebo

Matched capsule not containing any medication

Primary outcome measure

  • Change in Aortic Pulse Wave Velocity [ Time Frame: From Baseline to 180 days ]
  • Change in Gastrointestinal Angiodysplasia (GIAD) Foci [ Time Frame: From Baseline to 180 days ]
  • Change in Vascular Reactivity Index [ Time Frame: From Baseline to 180 days ]

Central Contacts and Locations

Central contacts

Omar Saeed, MD

718-920-2626osaeed@montefiore.org

Lorenzo D'Angelo, MD

718-920-2626

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10461

More Information

Sponsor

Montefiore Medical Center

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-01-23.