Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT06510322
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sildenafil — DRUG
    Orally administered phosphodiesterase-5 (PDE-5) inhibitor, which enhances nitric oxide signaling in platelets and blood vessels.
  • Placebo — OTHER
    Matched capsule not containing any medication

Study Details

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.

Key Dates

Start date
Mar 12, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change in Aortic Pulse Wave Velocity [ Time Frame: From Baseline to 180 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461-

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By research site
Montefiore Medical Center· The Bronx, NY

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