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OpenTrials
Completed

NCT Number: NCT01060020

Acute Hemodynamic Effects of Sildenafil in Patients With Severe Aortic Stenosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

Single oral dose of 40mg or 80mg of Sildenafil

Other names: Revatio, Viagra

Primary outcomes

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

    Time frame: Baseline and 60 minutes after drug administered

Secondary outcomes

  1. Percent Change in Pulmonary Vascular Resistance in the Whole Cohort.

    Time frame: Baseline and 60 minutes after drug administered

  2. Percent Change in Cardiac Index.

    Time frame: Baseline and 60 minutes after drug administered

    Cardiac index is cardiac output divided by body surface area.

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Barnes-Jewish Hospital

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 1, 2010
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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