Overview
Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2022-01-31
2022-01-31
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Duke UniversityCollaborator:
United States Department of DefenseTreatments:
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)