CompletedPhase 4

Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

United States20 participantsStarted 2010-01

Plain-language summary

Pulmonary hypertension is common in patients with aortic stenosis and is associated with worse operative and long-term outcomes. Sildenafil has been shown to reduce pulmonary artery pressure and improve exercise performance in patients with left-sided heart failure, but this has not been tested in patients with aortic stenosis. We hypothesize that Sildenafil will produce a clinically significant decrease in pulmonary artery pressure in patients with severe aortic stenosis. The dose of Sildenafil that produces a significant decrease in pulmonary artery pressure will be safe and well tolerated in patients with and without a depressed ejection fraction.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Severe aortic stenosis (AVA \< 1.0 cm2) * Referred for a clinically ordered right and left heart catheterization * 18 years of age and older * Able and willing to comply with all requirements of the study Exclusion Criteria: * Nitrate use within 24 hours * SBP \< 110 mmHg or MAP \< 75 mmHg * Severe mitral regurgitation * Severe aortic regurgitation * Increased risk of priapism * Retinal or optic nerve problems or unexplained visual disturbance * Alpha antagonists or cytochrome P450 3A4 inhibitors use within 24 hours * Current or recent (≤ 30 days) acute coronary syndrome * O2 sat \< 90% on room air * Females that are pregnant or believe they may be pregnant * Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable hemodynamic data * Unwilling to provide informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.

Timeframe: Baseline and 60 minutes after drug administered

Trial details

NCT IDNCT01060020

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-09

Results submitted2018-01-25

View on ClinicalTrials.gov More Aortic Stenosis trials