Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

Completed · Phase 4

Conditions studied: Aortic Stenosis

In brief

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.

Key facts

Study ID

NCT01060020

Run by

Washington University School of Medicine

People needed

20

Starts

2010-01-01

Expected to finish

2011-10-01

Last updated by the study team

2018-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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