Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05391737

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE) - a Case Control Study

Led by Dalarna County Council, Sweden · Updated on 2025-02-27

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Swimming Induced Pulmonary Edema (SIPE) is a condition that can occur during swimming in cold open water and is marked by sudden breathing difficulty, cough, excessive sputum, and sometimes coughing up blood. This research aims to better understand cardiac function in people with SIPE compared to swimmers without symptoms. It is a case-control study examining whether heart problems contribute to SIPE, as current knowledge and official guidelines for cardiac evaluation after SIPE are limited. The study includes about 12,000 swimmers at an annual open water event in Sweden called Vansbrosimningen. Participants are divided into two groups: those diagnosed with SIPE based on lung ultrasound and low oxygen levels during or after the swim, and matched swimmers without respiratory symptoms or pulmonary edema. The study evaluates heart function using echocardiography, electrocardiograms (ECG), and cardiac biomarkers (Troponin I and NT-pro-BNP) shortly after swimming and again at rest within 12 months. Participants will undergo acute heart tests within hours after swimming, including echocardiography and ECG focusing on heart rhythm, axis, intervals, and signs of ischemia, along with blood tests for cardiac biomarkers. They will also have baseline tests within a year after the swim. The study tracks these cardiac measures to assess heart function changes related to SIPE. The research is observational and includes ongoing safety monitoring, with participation lasting up to one year for follow-up assessments.

CONDITIONS

Brief Title

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • For patients: respiratory symptoms during or after swimming at the Vansbrosimningen open water event
  • For patients: diagnosis of SIPE by signs of pulmonary edema on lung ultrasound
  • For patients: peripheral oxygen saturation of 95% or higher
  • For controls: completion of a swimming race at the Vansbrosimningen event without respiratory symptoms
  • For controls: no signs of pulmonary edema on lung ultrasound
  • Controls matched to patients by age and sex
Not Eligible

You will not qualify if you...

  • Declined consent
  • Hemodynamic instability or decreased consciousness

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 6 hours after swimming

Participants undergo cardiac function tests including echocardiography, electrocardiogram (ECG), and cardiac biomarker measurements shortly after swimming to assess acute effects.

1 visit (in-person) within 6 hours after swimming

Long-term Monitoring

Duration - Up to 12 months after swimming

Participants have baseline cardiac assessments including echocardiography, ECG, and cardiac biomarkers performed within 12 months after swimming to evaluate cardiac function at rest.

1 visit (in-person) within 12 months after swimming

Trial Site Locations

Total: 1 location

1

Center of Clinical Research Dalarna

Falun, Sweden, 79182

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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