Clinical trial NCT05391737: Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)
Official title: Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE) - a Case Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Swimming Induced Pulmonary Edema (SIPE)
Pulmonary Edema
Lung Diseases
Heart Function Tests
Keywords: Echocardiography
Electrocardiography
Troponin
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adults (age ≥18 years) that participate in a swimming race during Vansbrosimningen open water swimming event.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Acute Echocardiography
timeFrame: within 4 hours after termination of swimming
measure: Acute Electrocardiogram (ECG) - Rytm analysis
timeFrame: within 4 hours after termination of swimming
measure: Acute Electrocardiogram (ECG) - Heart axis
timeFrame: within 4 hours after termination of swimming
measure: Acute Electrocardiogram (ECG) - Amplitudes and intervals
timeFrame: within 4 hours after termination of swimming
measure: Acute Electrocardiogram (ECG) - Signs of myocardial ischemia
timeFrame: within 4 hours after termination of swimming
measure: Acute cardiac biomarkers - Troponin I
timeFrame: 4-6 hours after termination of swimming
measure: Acute cardiac biomarkers - NT-pro-BNP
timeFrame: 4-6 hours after termination of swimming
Secondary outcomes:
measure: Baseline Echocardiography
timeFrame: within 12 months after swimming
measure: Baseline Electrocardiogram (ECG) - Rytm analysis
timeFrame: within 12 months after swimming
measure: Baseline Electrocardiogram (ECG)- Heart axis
timeFrame: within 12 months after swimming
measure: Baseline Electrocardiogram (ECG) - Amplitudes and intervals
timeFrame: within 12 months after swimming
measure: Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia
timeFrame: within 12 months after swimming
measure: Baseline cardiac biomarkers - Troponin I
timeFrame: within 12 months after swimming
measure: Baseline cardiac biomarkers - NT-pro-BNP
timeFrame: within 12 months after swimming
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Center of Clinical Research Dalarna
Study officials:
References: