Sildenafil for Vascular Changes During LVAD Support
This study is looking at whether sildenafil, a medication that helps blood vessels, can reduce problems with blood vessels that often happen when people have a left ventricular assist device (LVAD) to help their heart. LVADs help people with advanced heart failure, but they can sometimes lead to issues like stroke and bleeding due to changes in blood vessels. Researchers want to see if sildenafil can lessen these changes, which are sometimes called "vascular aging." You might be able to join if you are over 18, have an LVAD or are planning to get one, and can give informed consent. You cannot join if you have certain pre-existing heart conditions, an allergy to sildenafil, or take certain other medications. The study will measure changes in blood vessel stiffness and look at small blood vessels in the digestive tract using a video capsule endoscopy. The current status of this study is unclear.
- Study design
- This study plans to enroll 50 participants. It is an interventional study, meaning participants will receive either sildenafil or a placebo (a capsule without medication).
- What's involved
- The study will measure changes in your blood vessels and gastrointestinal angiodysplasia (GIAD) foci over 180 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in their blood vessels and GIAD foci for 180 days after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Sildenafil to Reduce Vascular Remodeling During Left Ventricular Assist Device Support
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Omar Saeed, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Change in Aortic Pulse Wave VelocityFrom 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) FociFrom 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 IndexFrom 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.