Phase 4
Completed N=20
Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis
Source: ClinicalTrials.gov NCT01060020 ↗Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Apr 2018
Primary outcomePrimary: Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort. — -25 percent change
◆ Published Evidence
Established
73citations · ~5 / year
Effects of phosphodiesterase type 5 inhibition on systemic and pulmonary hemodynamics and ventricular function in patients with severe symptomatic aortic stenosis.
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.
Linked Publications
-
Effects of phosphodiesterase type 5 inhibition on systemic and pulmonary hemodynamics and ventricular function in patients with severe symptomatic aortic stenosis.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT01060020) and the linked publication. 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. Informational only — not medical advice.