Brief Title
Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis
Official Title
Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis
Brief 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.
Detailed Description
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.
Secondary Outcome
Percent Change in Pulmonary Vascular Resistance in the Whole Cohort.
Condition
Aortic Stenosis
Intervention
Sildenafil
Study Arms / Comparison Groups
Sildenafil 40mg or 80mg
Description: A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (<50%) EF.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
January 2010
Completion Date
October 2011
Primary Completion Date
September 2011
Eligibility 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Brian R. Lindman, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01060020
Organization ID
09-1780
Responsible Party
Principal Investigator
Study Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
Study Sponsor
Brian R. Lindman, MD, Principal Investigator, Washington University School of Medicine
Verification Date
April 2018