Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis
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|ClinicalTrials.gov Identifier: NCT01060020|
Recruitment Status : Completed
First Posted : February 1, 2010
Results First Posted : April 25, 2018
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Aortic Stenosis||Drug: Sildenafil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||October 2011|
Experimental: Sildenafil 40mg or 80mg
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.
Single oral dose of 40mg or 80mg of Sildenafil
- Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort. [ Time Frame: Baseline and 60 minutes after drug administered ]
- Percent Change in Pulmonary Vascular Resistance in the Whole Cohort. [ Time Frame: Baseline and 60 minutes after drug administered ]
- Percent Change in Cardiac Index. [ Time Frame: Baseline and 60 minutes after drug administered ]Cardiac index is cardiac output divided by body surface area.
- Load Independent Index of Diastolic Filling. [ 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).
- Global Longitudinal Strain [ Time Frame: Baseline and 60 minutes after drug administered ]Global longitudinal strain was measured at baseline and 60 minutes after drug administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060020
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Brian R. Lindman, MD||Washington University School of Medicine|