NCT05391737·Not applicable·OBSERVATIONAL

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

Nesiritide Other Recruiting

Status

Recruiting

Phase

Not applicable

Enrollment

120

Locations

Results

Not posted

Publications

Study summary

What the protocol is testing.

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.

Full 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).

Interventions

Treatment arms and agents.

DIAGNOSTIC_TEST

Echocardiography

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

DIAGNOSTIC_TEST

Electrocardiogram (ECG)

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

DIAGNOSTIC_TEST

Cardiac biomarkers

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

Timeline

From registration to results.

First posted
May 26, 2022
Study start
Jul 6, 2022
Primary completion
Dec 2026
Study completion
Dec 2026
Results posted
Not reported
Registry updated
Feb 27, 2025

Outcomes

What the study measures.

Primary outcomes

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.

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)

Acute Electrocardiogram (ECG) - Heart axis

Time frame · within 4 hours after termination of swimming

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

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)

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.

Acute cardiac biomarkers - Troponin I

Time frame · 4-6 hours after termination of swimming

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

Acute cardiac biomarkers - NT-pro-BNP

Time frame · 4-6 hours after termination of swimming

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