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Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
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.
Details
| Lead sponsor | Montefiore Medical Center |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | RECRUITING |
| Enrolment | 50 |
| Start date | 2025-03-12 |
| Completion | 2029-12 |
Conditions
- Vascular Diseases
Interventions
- Sildenafil
- Placebo
Primary outcomes
- Change in Aortic Pulse Wave Velocity — From Baseline to 180 days
Pulse wave velocity (PWV) will be measured by vascular ultrasound. PWV will be calculated by dividing the distance between the carotid and femoral artery waveform acquisition sites (in meters) by the carotid-femoral transit time (change in time, in seconds). Change in group mean PWV from baseline will be summarized. Increases in PWV can be an indicator of vascular fibrosis and are associated with increased risk of cardiovascular comorbidities. - Change in Gastrointestinal Angiodysplasia (GIAD) Foci — From Baseline to 180 days
Microvascular angiodysplasia will be assessed by video capsule endoscopy (VCE). VCE is a minimally invasive technique used to identify gastrointestinal lesions and diagnose GIAD. Change in the group mean number of GIAD foci/lesions per patient from baseline to 180 days will be determined. GIAD formation will only be assessed at baseline and at 180 days unless the patient(s) experiences an episode of gastrointestinal bleeding prior to 180 days. - Change in Vascular Reactivity Index — From Baseline to 180 days
Endothelial function will be determined by the finger vascular reactivity index (VRI) during LVAD support. VRI will be assessed by a non-invasive method using the Endothelix device. VRI is determined by measuring fingertip temperature change before and after cuff deflation. Change in group median VRI values from baseline will be summarized. Positive changes from baseline are associated with improved endothelial function.
Countries
United States