Phase 4 N=20 Treatment

Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

Aortic Stenosis

Bottom Line

View on ClinicalTrials.gov: NCT01060020 ↗

Enrolled (actual)

Serious AEs

15.0%

Results posted

Apr 2018

Primary outcome: Primary: Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort. — -25 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Sildenafil (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.	-25	—
SECONDARY Percent Change in Pulmonary Vascular Resistance in the Whole Cohort.	-29	—
SECONDARY Percent Change in Cardiac Index.	4	—
SECONDARY Load Independent Index of Diastolic Filling.	1.02; 1.03	—
SECONDARY Global Longitudinal Strain	-13.5; -13.8	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01060020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.