Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Barnes-Jewish Hospital
• Treatments: Sildenafil Citrate

Criteria

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