Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05391737

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

Acute or chronic cardiac dysfunction could be a contributing factor to swimming-induced pulmonary edema (SIPE). Knowledge on cardiac function in SIPE is limited and recommendations for cardiac evaluation of patients with SIPE are lacking. The present study was designed to assess cardiac function in patients with SIPE and in asymptomatic swimmers.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Swimming Induced Pulmonary Edema (SIPE) Heart Function Tests Lung Diseases Pulmonary Edema Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Center of Clinical Research Dalarna

Falun, 79182, Sweden

Location status: Recruiting

Location contact

Maria Hårdstedt, MD/PhD

CONTACT

[email protected]

+46 738089464

About this study

Swimming induced pulmonary edema (SIPE) is an unusual condition occuring during swimming in cold open water. SIPE is characterized by acute onset of dyspnea and cough, excessive sputum and occasionally hemoptysis. Reversible myocardial dysfunction has been described in swimmers with SIPE and divers with immersion pulmonary edema (IPE). Cardiac dysfunction has also been discussed as a contributing factor triggering SIPE. However, prevalence, severity and prognosis of myocardial dysfunction in patients with SIPE is unknown. Official recommendations for cardiac evaluation of patients after an acute episode of SIPE is lacking.

This case-control-study intends to assess cardiac function in patients with SIPE and in asymptomatic swimmers. We study a large cohort of approximately 12 000 swimmers during Vansbrosimningen, Sweden's biggest annual open water event, with a yearly incidence of SIPE of about 0,4%. Cardiac function is evaluated after swimming as well as at rest by echocardiography, 12-lead electrocardiogram and cardiac biomarkers (Troponin I, NT-pro-BNP).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients:

  • respiratory symptoms during or after swimming at the Vansbrosimningen open water swimming event
  • diagnosis SIPE by signs of pulmonary edema on lung ultrasound
  • peripheral oxygen saturation ≤95%

for controls:

  • completion of a swimming race of the Vansbrosimningen open water swimming event.
  • no respiratory symptoms during or after swimming
  • no signs of pulmonary edema on lung ultrasound
  • matched to patients with SIPE regarding sex and age

Exclusion criteria

  • declined consent
  • hemodynamic instability or decreased consciousness

Treatment and study plan

Echocardiography

Diagnostic Test

Echocardiography after swimming (acute) and at rest (baseline)

Electrocardiogram (ECG)

Diagnostic Test

Electrocardiogram (ECG) after swimming (acute) and at rest (baseline)

Cardiac biomarkers

Diagnostic Test

high sensitive (hs)-Troponin I and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) after swimming (acute) and at rest (baseline)

Primary outcomes

  1. Acute Echocardiography

    Time frame: within 4 hours after termination of swimming

    Transthoracic echocardiography with parasternal, apical and subcostal views. Including measurement of ventricular wall size, left ventricular strain, ejection fraction according to the modified Simpson method, diastolic function (using tissue doppler, mitral flow and pulmonary vein flow), right ventricular tricuspid annular plane systolic excursion (TAPSE), pressure gradient over the tricuspid valve, assessment of valve dysfunction, size and respiratory variation of the inferior vena cava, assessment of pericardial fluid.

  2. Acute Electrocardiogram (ECG) - Rytm analysis

    Time frame: within 4 hours after termination of swimming

    12-lead electrocardiogram (ECG). Rytm analysis and frequency (beats per minute)

  3. Acute Electrocardiogram (ECG) - Heart axis

    Time frame: within 4 hours after termination of swimming

    12-lead electrocardiogram (ECG). Assessment of QRS-axis (degrees)

  4. Acute Electrocardiogram (ECG) - Amplitudes and intervals

    Time frame: within 4 hours after termination of swimming

    12-lead electrocardiogram (ECG). Duration of PQ-interval (ms), QRS-complex (ms), QT-interval (ms), QRS amplitude (mV)

  5. Acute Electrocardiogram (ECG) - Signs of myocardial ischemia

    Time frame: within 4 hours after termination of swimming

    12-lead electrocardiogram (ECG). ST-elevation, ST-depression, T-wave inversion, Q wave.

  6. Acute cardiac biomarkers - Troponin I

    Time frame: 4-6 hours after termination of swimming

    Venous samples. Measurement of hs-Troponin I (ng/L).

  7. Acute cardiac biomarkers - NT-pro-BNP

    Time frame: 4-6 hours after termination of swimming

    Venous samples. Measurement of NT-pro-BNP (ng/L)

Secondary outcomes

  1. Baseline Echocardiography

    Time frame: within 12 months after swimming

    Transthoracic echocardiography with parasternal, apical and subcostal views. Examination at rest. Including measurement of ventricular wall size, left ventricular strain, ejection fraction according to the modified Simpson method, diastolic function (using tissue doppler, mitral flow and pulmonary vein flow), right ventricular tricuspid annular plane systolic excursion (TAPSE), pressure gradient over the tricuspid valve, assessment of valve dysfunction, size and respiratory variation of the inferior vena cava, assessment of pericardial fluid.

  2. Baseline Electrocardiogram (ECG) - Rytm analysis

    Time frame: within 12 months after swimming

    12-lead Electrocardiogram (ECG). Examination at rest. Rytm analysis and frequency (beats per minute)

  3. Baseline Electrocardiogram (ECG)- Heart axis

    Time frame: within 12 months after swimming

    12-lead Electrocardiogram (ECG). Examination at rest. Assessment of QRS-axis (degrees)

  4. Baseline Electrocardiogram (ECG) - Amplitudes and intervals

    Time frame: within 12 months after swimming

    12-lead Electrocardiogram (ECG). Examination at rest. Duration of PQ-interval (ms), QRS-complex (ms), QT-interval (ms), QRS amplitude (mV)

  5. Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia

    Time frame: within 12 months after swimming

    12-lead Electrocardiogram (ECG). Examination at rest. ST-elevation, ST-depression, T-wave inversion, Q wave.

  6. Baseline cardiac biomarkers - Troponin I

    Time frame: within 12 months after swimming

    Venous samples. Measurement of hs-Troponin I (ng/L). Examination at rest

  7. Baseline cardiac biomarkers - NT-pro-BNP

    Time frame: within 12 months after swimming

    Venous samples. Measurement of NT-pro-BNP (ng/L). Examination at rest

Sponsors and collaborators

Lead sponsor

Dalarna County Council, Sweden

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 26, 2022
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.