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Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

Primary Purpose

Aortic Stenosis

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sildenafil

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring Aortic valve stenosis, Sildenafil, Phosphodiesterase inhibitors, Hypertension, Pulmonary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sildenafil 40mg or 80mg

Arm 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.

Outcomes

Primary Outcome Measures

Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.

Secondary Outcome Measures

Percent Change in Pulmonary Vascular Resistance in the Whole Cohort.

Percent Change in Cardiac Index.

Cardiac index is cardiac output divided by body surface area.

Load Independent Index of Diastolic Filling.

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

Global longitudinal strain was measured at baseline and 60 minutes after drug administration.

Full Information

NCT ID

NCT01060020

First Posted

January 28, 2010

Last Updated

April 16, 2018

Sponsor

Washington University School of Medicine

Collaborators

Barnes-Jewish Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01060020

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington University School of Medicine

Collaborators

Barnes-Jewish Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Stenosis

Keywords

Aortic valve stenosis, Sildenafil, Phosphodiesterase inhibitors, Hypertension, Pulmonary

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sildenafil 40mg or 80mg

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Other Intervention Name(s)

Revatio, Viagra

Intervention Description

Single oral dose of 40mg or 80mg of Sildenafil

Primary Outcome Measure Information:

Title

Percent Change in Mean Pulmonary Artery Pressure in the Whole Cohort.

Time Frame