Swimming Induced Pulmonary Edema (SIPE)NCT05391737

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

An observational study of Swimming Induced Pulmonary Edema (SIPE) and Pulmonary Edema, run by Dalarna County Council, Sweden at 1 site in Sweden.

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Sites and contacts

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases
What is being tested?: Echocardiography, Electrocardiogram (ECG) and Cardiac biomarkers
How many people: 120 participants
Where: 1 siteSweden
Study dates: 6 Jul 2022to Dec 2027
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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.

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no respiratory symptoms during or after swimming
no signs of pulmonary edema on lung ultrasound
matched to patients with SIPE regarding sex and age

Who cannot join

declined consent
hemodynamic instability or decreased consciousness

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden1 site, 1 recruiting

Center of Clinical Research Dalarna
Falun, 79182
Maria Hårdstedt, MD/PhD, +46 738089464, maria.hardstedt@regiondalarna.se
Recruiting

Other trials in Sweden

About this study

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

Read the 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).

Conditions: Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases, Heart Function Tests
Being tested: Echocardiography, Electrocardiogram (ECG), Cardiac biomarkers
Keywords: Echocardiography, Electrocardiography, Troponin
Medical subject headings: Pulmonary Edema, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05391737
Study group	Role	What they receive
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. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram (ECG); Diagnostic Test: Cardiac biomarkers
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. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram (ECG); Diagnostic Test: Cardiac biomarkers

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jul 2022Dec 2027

First posted26 May 2022
Study start6 Jul 2022
Primary completionDec 2027 (estimated)
Study completionDec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Swimming Induced Pulmonary Edema (SIPE)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05391737
Sponsor's protocol ID: SIPE Cardiac function 001
Status last verified: Sep 2026
First submitted: 17 May 2022
Last updated: 5 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Seiler C, Torola M, Knuts U, Holm L, Magnusson B, Rask P, Nilsson KF, Hardstedt M. Cardiac Findings in Swimming-Induced Pulmonary Edema: Implications for Acute Assessment. Chest. 2026 Jul 10:S0012-3692(26)00962-1. doi: 10.1016/j.chest.2026.06.051. Online ahead of print.
PubMed 42431395

Interested in taking part?

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Questions to ask the study team

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See sites and contacts

Recruiting
O2 Versus CPAP Treatment Of Patients Undergoing SIPE Therapy (OCTOPUS)
Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema
Recruiting
PEP-device for Treatment of Swimming-induced Pulmonary Edema (SIPE)
Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema

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