Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Diseases; Pulmonary Edema; Heart Function Tests; Swimming Induced Pulmonary Edema (SIPE)
• Intervention / Treatment: Diagnostic test: Echocardiography; Diagnostic test: Electrocardiogram (ECG); Diagnostic test: Cardiac biomarkers

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• Sweden
  • Falun, Sweden, 79182
    • Recruiting
    • Center of Clinical Research Dalarna
    • Contact: Maria Hårdstedt, MD/PhD; Phone Number: +46 738089464; Email: maria.hardstedt@regiondalarna.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All adults (age ≥18 years) that participate in a swimming race during Vansbrosimningen open water swimming event.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Acute Electrocardiogram (ECG) - Rytm analysis	12-lead electrocardiogram (ECG). Rytm analysis and frequency (beats per minute)	within 4 hours after termination of swimming
Acute Electrocardiogram (ECG) - Heart axis	12-lead electrocardiogram (ECG). Assessment of QRS-axis (degrees)	within 4 hours after termination of swimming
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
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
Acute cardiac biomarkers - Troponin I	Venous samples. Measurement of hs-Troponin I (ng/L).	4-6 hours after termination of swimming
Acute cardiac biomarkers - NT-pro-BNP	Venous samples. Measurement of NT-pro-BNP (ng/L)	4-6 hours after termination of swimming

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Baseline Electrocardiogram (ECG) - Rytm analysis	12-lead Electrocardiogram (ECG). Examination at rest. Rytm analysis and frequency (beats per minute)	within 12 months after swimming
Baseline Electrocardiogram (ECG)- Heart axis	12-lead Electrocardiogram (ECG). Examination at rest. Assessment of QRS-axis (degrees)	within 12 months after swimming
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
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
Baseline cardiac biomarkers - Troponin I	Venous samples. Measurement of hs-Troponin I (ng/L). Examination at rest	within 12 months after swimming
Baseline cardiac biomarkers - NT-pro-BNP	Venous samples. Measurement of NT-pro-BNP (ng/L). Examination at rest	within 12 months after swimming

Collaborators and Investigators

• Sponsor: Dalarna County Council, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 17, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Echocardiography; Electrocardiography; Troponin
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Edema; Pulmonary Edema
• Other Study ID Numbers: SIPE Cardiac function 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No