Overview

Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention

Status:
Enrolling by invitation
Trial end date:
2022-01-31
Target enrollment:
0
Participant gender:
All
Summary
This trial is testing the effectiveness of a single oral dose of sildenafil (50 mg) taken 1 hour before a provocative event on the subsequent development of swimming-induced pulmonary edema.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Duke University
Collaborator:
United States Department of Defense
Treatments:
Sildenafil Citrate
Criteria
Inclusion Criteria:

- Healthy volunteers between 18 and 45 years

- History of swimming-induced pulmonary edema

Exclusion Criteria:

- Pregnant women

- Significant heart valve disease

- Cardiomyopathy

- Uncontrolled hypertension

- Coronary artery disease

- Obstructive lung disease

- VO2max <25 mL/kg as estimated by the University of Houston Non-Exercise Test

- Previous adverse reaction to sildenafil

- Use of antihypertensives or other drugs that are known to interact adversely with
sildenafil (e.g. nitrates, alpha adrenergic blockers)