Phase 2
N=18
Sildenafil for Swimming-Induced Pulmonary Edema (SIPE) Prevention
Edema, Pulmonary · Immersion · Diving
Bottom Line
View on ClinicalTrials.gov: NCT03686813 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Nov 2022
Primary outcome: Primary: Number of Participants With Pulmonary Edema — 7; 9 Participants — p=0.317
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sildenafil Citrate (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pulmonary Edema |
7; 9 | 0.317 |
| SECONDARY Number of Participants With Dyspnea Leading to Voluntary Premature Cessation of Exercise |
10; 8 | 0.317 |
| SECONDARY Number of Participants With Post-exercise 10% Decrease in Forced Vital Capacity (FVC) or Forced Expiratory Volume in One Second (FEV1) as Measured by Spirometry |
3; 3 | >0.999 |
| SECONDARY Number of Participants With "Comet Tails" Seen on Ultrasound of the Lungs |
17; 14 | 0.18 |
| SECONDARY Number of Participants Who Found the Exercise Easiest When Given Sildenafil Citrate Versus When Given Placebo |
5; 9; 4 | 0.29 |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT03686813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.