Washington University School of Medicine
St Louis, Missouri, 63110, United States
NCT Number: NCT01060020
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
St Louis, Missouri, 63110, United States
Patients with severe aortic stenosis referred for a clinically ordered right and left heart catheterization will be eligible. Twenty subjects will be enrolled: 10 patients will receive 40mg and 10 patients will receive 80mg; each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF. Subjects will get a baseline echo prior to the heart catheterization. Baseline invasive hemodynamic measurements will be performed using a Swan Ganz catheter. A single oral dose of sildenafil will then be administered (40mg or 80mg), followed by invasive hemodynamic measurements at 30 and 60 minutes. Also at 60 minutes, limited echocardiographic images will be obtained.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single oral dose of 40mg or 80mg of Sildenafil
Other names: Revatio, Viagra
Time frame: Baseline and 60 minutes after drug administered
Time frame: Baseline and 60 minutes after drug administered
Time frame: Baseline and 60 minutes after drug administered
Cardiac index is cardiac output divided by body surface area.
Time frame: Baseline and 60 minutes after drug administered
Measurements of the load independent index of diastolic filling were made with the parameterized diastolic filling formalism as previously described and validated with the use of transmitral Doppler E waves recorded during different respiratory states (regular breathing and held expiration and inspiration).
Time frame: Baseline and 60 minutes after drug administered
Global longitudinal strain was measured at baseline and 60 minutes after drug administration.
Washington University School of Medicine
Other
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