Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

Recruiting

• Conditions: Swimming Induced Pulmonary Edema (SIPE); Lung Diseases; Pulmonary Edema; Heart Function Tests
• Interventions: Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram (ECG); Diagnostic Test: Cardiac biomarkers

• Registration Number: NCT05391737
• Lead Sponsor: Dalarna County Council, Sweden

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2022-05-17
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-26
• Study Start: 2022-07-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Echocardiography	Swimmers completing "Vansbrosimningen" without respiratory symptoms or signs of pulmonary edema on lung ultrasound. Matched to patients with SIPE for age and gender.
patients with SIPE	Cardiac biomarkers	Adult patients (age ≥18 years) with SIPE-diagnosis during "Vansbrosimningen" and peripheral oxygen saturation ≤95%. SIPE-diagnosis based on pulmonary edema on lung ultrasound.
control group	Cardiac biomarkers	Swimmers completing "Vansbrosimningen" without respiratory symptoms or signs of pulmonary edema on lung ultrasound. Matched to patients with SIPE for age and gender.
patients with SIPE	Echocardiography	Adult patients (age ≥18 years) with SIPE-diagnosis during "Vansbrosimningen" and peripheral oxygen saturation ≤95%. SIPE-diagnosis based on pulmonary edema on lung ultrasound.
patients with SIPE	Electrocardiogram (ECG)	Adult patients (age ≥18 years) with SIPE-diagnosis during "Vansbrosimningen" and peripheral oxygen saturation ≤95%. SIPE-diagnosis based on pulmonary edema on lung ultrasound.
control group	Electrocardiogram (ECG)	Swimmers completing "Vansbrosimningen" without respiratory symptoms or signs of pulmonary edema on lung ultrasound. Matched to patients with SIPE for age and gender.

Primary Outcome Measures

Name	Time	Method
Acute cardiac biomarkers - Troponin I	4-6 hours after termination of swimming	Venous samples. Measurement of hs-Troponin I (ng/L).
Acute cardiac biomarkers - NT-pro-BNP	4-6 hours after termination of swimming	Venous samples. Measurement of NT-pro-BNP (ng/L)
Acute Echocardiography	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.
Acute Electrocardiogram (ECG) - Rytm analysis	within 4 hours after termination of swimming	12-lead electrocardiogram (ECG). Rytm analysis and frequency (beats per minute)
Acute Electrocardiogram (ECG) - Amplitudes and intervals	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)
Acute Electrocardiogram (ECG) - Heart axis	within 4 hours after termination of swimming	12-lead electrocardiogram (ECG). Assessment of QRS-axis (degrees)
Acute Electrocardiogram (ECG) - Signs of myocardial ischemia	within 4 hours after termination of swimming	12-lead electrocardiogram (ECG). ST-elevation, ST-depression, T-wave inversion, Q wave.

Secondary Outcome Measures

Name	Time	Method
Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia	within 12 months after swimming	12-lead Electrocardiogram (ECG). Examination at rest. ST-elevation, ST-depression, T-wave inversion, Q wave.
Baseline cardiac biomarkers - NT-pro-BNP	within 12 months after swimming	Venous samples. Measurement of NT-pro-BNP (ng/L). Examination at rest
Baseline Electrocardiogram (ECG) - Amplitudes and intervals	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)
Baseline Echocardiography	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.
Baseline Electrocardiogram (ECG) - Rytm analysis	within 12 months after swimming	12-lead Electrocardiogram (ECG). Examination at rest. Rytm analysis and frequency (beats per minute)
Baseline Electrocardiogram (ECG)- Heart axis	within 12 months after swimming	12-lead Electrocardiogram (ECG). Examination at rest. Assessment of QRS-axis (degrees)
Baseline cardiac biomarkers - Troponin I	within 12 months after swimming	Venous samples. Measurement of hs-Troponin I (ng/L). Examination at rest

Trial Locations

Locations (1)

Center of Clinical Research Dalarna; 🇸🇪 Falun, Sweden