Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/27/2018 |
| Start Date: | January 2010 |
| End Date: | October 2011 |
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.
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.
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.
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.
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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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