Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391737
• Other study ID #: SIPE Cardiac function 001
• Status: Recruiting
• Start date: July 6, 2022
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Dalarna County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Echocardiography
Echocardiography after swimming (acute) and at rest (baseline)
• Electrocardiogram (ECG)
Electrocardiogram (ECG) after swimming (acute) and at rest (baseline)
• Cardiac biomarkers
high sensitive (hs)-Troponin I and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) after swimming (acute) and at rest (baseline)

Locations

Country	Name	City	State
Sweden	Center of Clinical Research Dalarna	Falun

Sponsors (1)

Lead Sponsor	Collaborator
Dalarna County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Echocardiography	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.	within 4 hours after termination of swimming
Primary	Acute Electrocardiogram (ECG) - Rytm analysis	12-lead electrocardiogram (ECG). Rytm analysis and frequency (beats per minute)	within 4 hours after termination of swimming
Primary	Acute Electrocardiogram (ECG) - Heart axis	12-lead electrocardiogram (ECG). Assessment of QRS-axis (degrees)	within 4 hours after termination of swimming
Primary	Acute Electrocardiogram (ECG) - Amplitudes and intervals	12-lead electrocardiogram (ECG). Duration of PQ-interval (ms), QRS-complex (ms), QT-interval (ms), QRS amplitude (mV)	within 4 hours after termination of swimming
Primary	Acute Electrocardiogram (ECG) - Signs of myocardial ischemia	12-lead electrocardiogram (ECG). ST-elevation, ST-depression, T-wave inversion, Q wave.	within 4 hours after termination of swimming
Primary	Acute cardiac biomarkers - Troponin I	Venous samples. Measurement of hs-Troponin I (ng/L).	4-6 hours after termination of swimming
Primary	Acute cardiac biomarkers - NT-pro-BNP	Venous samples. Measurement of NT-pro-BNP (ng/L)	4-6 hours after termination of swimming
Secondary	Baseline Echocardiography	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.	within 12 months after swimming
Secondary	Baseline Electrocardiogram (ECG) - Rytm analysis	12-lead Electrocardiogram (ECG). Examination at rest. Rytm analysis and frequency (beats per minute)	within 12 months after swimming
Secondary	Baseline Electrocardiogram (ECG)- Heart axis	12-lead Electrocardiogram (ECG). Examination at rest. Assessment of QRS-axis (degrees)	within 12 months after swimming
Secondary	Baseline Electrocardiogram (ECG) - Amplitudes and intervals	12-lead Electrocardiogram (ECG). Examination at rest. Duration of PQ-interval (ms), QRS-complex (ms), QT-interval (ms), QRS amplitude (mV)	within 12 months after swimming
Secondary	Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia	12-lead Electrocardiogram (ECG). Examination at rest. ST-elevation, ST-depression, T-wave inversion, Q wave.	within 12 months after swimming
Secondary	Baseline cardiac biomarkers - Troponin I	Venous samples. Measurement of hs-Troponin I (ng/L). Examination at rest	within 12 months after swimming
Secondary	Baseline cardiac biomarkers - NT-pro-BNP	Venous samples. Measurement of NT-pro-BNP (ng/L). Examination at rest	within 12 months after swimming