← Back to Search

Phosphodiesterase Inhibitor

Sildenafil for Vascular Disease

Phase < 1

Waitlist Available

Led By Omar Saeed, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Over 18 years of age

Be older than 18 years old

Must not have

Taking any nitric oxide donor medications

History of complete carotid occlusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 180 days

Summary

"This trial aims to see if using sildenafil, a medication that can reduce vascular aging, can help prevent major complications like stroke and bleeding in patients with advanced heart failure who are being treated with left ventricular

Who is the study for?

This trial is for adults over 18 who are receiving durable left ventricular assist device (LVAD) support and can give informed consent. It's not suitable for those with a pre-existing aortic valve prosthesis or graft, allergy to sildenafil, complete carotid occlusion, or those taking nitric oxide donor medications.

What is being tested?

The study is testing if sildenafil can slow down vascular aging in patients with LVADs. Vascular aging often leads to strokes and bleeding. Participants will either receive sildenafil or a placebo without knowing which one they're getting.

What are the potential side effects?

Sildenafil may cause headaches, flushing, indigestion, nasal congestion, dizziness, and vision changes. However, the severity of side effects varies from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not taking any medications that donate nitric oxide.

Select...

I have had a complete blockage in my carotid artery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Aortic Pulse Wave Velocity

Secondary study objectives

Change in Gastrointestinal Angiodysplasia (GIAD) Foci

Change in Urinary Protein to Creatinine Ratio (ACR)

Change in Vascular Reactivity Index

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SildeanfilActive Control1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

Participants in this arm will receive matching placebo, which serves as a negative control to understand changes in small and large blood vessels.

0 / 3Eligibility criteria met