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Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study drug, Sildenafil, will work in preventing Swimming-Induced Pulmonary Edema (SIPE) in patients who have shown SIPE symptoms before.

What is the Condition Being Studied?

Immersion Pulmonary Edema, Swimming-Induced Pulmonary Edema (SIPE)

Who Can Participate in the Study?

Adults who:
- Are aged 18 - 45 years old
- Have experienced immersion pulmonary edema (swimming-induced pulmonary edema, SIPE) symptoms before

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Exercise on a stationary bike
- Have a breathing test
- Have your blood pressure checked
- Have an ultrasound of your lungs and possibly your heart
- Have an Electrocardiogram (EKG)
- Have a blood sample taken
- If you have not already had one, you will have an echocardiogram while resting and while exercising

Later in this study, you will drink Pedialyte (like Gatorade) and you will get either sildenafil or an inactive tablet. Neither you nor the doctors will know which one you get until the study is over.

You will then perform exercise in cold (20°C) water with your head out for 40 minutes.
-- During the exercise, you will be watched for symptoms of SIPE and blood oxygen level by EKG and a blood pressure cuff
-- If you develop SIPE you will be removed from the water and if needed get treatment and possibly a chest x-ray
-- This exercise will be completed twice, at least one week apart

Study Details

Full Title
Sildenafil for Prevention of Swimming-Induced Pulmonary Edema (SIPE)
Principal Investigator
Anesthesiologist
Protocol Number
IRB:PRO00100971
NCT:NCT03686813
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698