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.
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
- Are there results?
- Not yet: the study is under way
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.
Show all 9Show fewer
- 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
- Recruiting
Center of Clinical Research Dalarna
Falun, 79182
Maria Hårdstedt, MD/PhD, +46 738089464, maria.hardstedt@regiondalarna.se
About this study
Official title: 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.
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Hårdstedt, Dalarna County Council, Sweden
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE) - a Case Control Study
- ClinicalTrials.gov ID
- NCT05391737
- Acronym / sponsor ID
- SIPE Cardiac function 001
- Conditions
- Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema, Lung Diseases, Heart Function Tests
- Keywords
- Echocardiography, Electrocardiography, Troponin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with SIPE | – | Diagnostic Test: Echocardiography, Diagnostic Test: Electrocardiogram (ECG), Diagnostic Test: Cardiac biomarkersAdult patients (age ≥18 years) with SIPE-diagnosis during "Vansbrosimningen" and peripheral oxygen saturation ≤95%. SIPE-diagnosis based on pulmonary edema on lung ultrasound. |
| control group | – | Diagnostic Test: Echocardiography, Diagnostic Test: Electrocardiogram (ECG), Diagnostic Test: Cardiac biomarkersSwimmers completing "Vansbrosimningen" without respiratory symptoms or signs of pulmonary edema on lung ultrasound. Matched to patients with SIPE for age and gender. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All adults (age ≥18 years) that participate in a swimming race during Vansbrosimningen open water swimming event.
Key inclusion criteria (9 listed)
- 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%
- completion of a swimming race of the Vansbrosimningen open water swimming event.
- no respiratory symptoms during or after swimming
Key exclusion criteria (2 listed)
- declined consent
- hemodynamic instability or decreased consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EchocardiographyEchocardiography after swimming (acute) and at rest (baseline) | Diagnostic test | control group, patients with SIPE |
| Electrocardiogram (ECG)Electrocardiogram (ECG) after swimming (acute) and at rest (baseline) | Diagnostic test | control group, patients with SIPE |
| Cardiac biomarkershigh sensitive (hs)-Troponin I and N-terminal pro-brain natriuretic peptide (NT-pro-BNP) after swimming (acute) and at rest (baseline) | Diagnostic test | control group, patients with SIPE |
Primary outcome
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)
7 secondary outcomes
Baseline Echocardiography
Time frame: within 12 months after swimming
Baseline Electrocardiogram (ECG) - Rytm analysis
Time frame: within 12 months after swimming
Baseline Electrocardiogram (ECG)- Heart axis
Time frame: within 12 months after swimming
Baseline Electrocardiogram (ECG) - Amplitudes and intervals
Time frame: within 12 months after swimming
Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia
Time frame: within 12 months after swimming
Baseline cardiac biomarkers - Troponin I
Time frame: within 12 months after swimming
Baseline cardiac biomarkers - NT-pro-BNP
Time frame: within 12 months after swimming
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 42431395Seiler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Swimming Induced Pulmonary Edema (SIPE) and Pulmonary Edema, run by Dalarna County Council, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Echocardiography (time frame: within 4 hours after termination of swimming). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05391737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.