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RecruitingNCT05391737Updated Oct 5, 2026

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

An observational study in Swimming Induced Pulmonary Edema (SIPE), Pulmonary Edema and Lung Diseases, sponsored by Dalarna County Council, Sweden. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Dalarna County Council, Sweden · Observational

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 4 months later.
Updated Oct 5, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

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).

02

Conditions studied

  • Swimming Induced Pulmonary Edema (SIPE)
  • Pulmonary Edema
  • Lung Diseases
  • Heart Function Tests

Keywords

  • Echocardiography
  • Electrocardiography
  • Troponin
03

In context

Pulmonary Edema

126 studies on the registry are indexed under Pulmonary Edema; 27 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 55 observational studies indexed under Pulmonary Edema.

Browse Pulmonary Edema studies →

Lead sponsor

Dalarna County Council, Sweden is the lead sponsor of 28 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • declined consent
  • hemodynamic instability or decreased consciousness
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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 · 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.

    Diagnostic Test: Echocardiography · Diagnostic Test: Electrocardiogram (ECG) · Diagnostic Test: Cardiac biomarkers

Interventions

  • Diagnostic testEchocardiography

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

  • Diagnostic testElectrocardiogram (ECG)

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

  • Diagnostic testCardiac biomarkers

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: within 4 hours after termination of swimming

  2. Acute Electrocardiogram (ECG) - Rytm analysis

    12-lead electrocardiogram (ECG). Rytm analysis and frequency (beats per minute)

    Time frame: within 4 hours after termination of swimming

  3. Acute Electrocardiogram (ECG) - Heart axis

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

    Time frame: within 4 hours after termination of swimming

  4. Acute Electrocardiogram (ECG) - Amplitudes and intervals

    12-lead electrocardiogram (ECG). Duration of PQ-interval (ms), QRS-complex (ms), QT-interval (ms), QRS amplitude (mV)

    Time frame: within 4 hours after termination of swimming

  5. Acute Electrocardiogram (ECG) - Signs of myocardial ischemia

    12-lead electrocardiogram (ECG). ST-elevation, ST-depression, T-wave inversion, Q wave.

    Time frame: within 4 hours after termination of swimming

  6. Acute cardiac biomarkers - Troponin I

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

    Time frame: 4-6 hours after termination of swimming

  7. Acute cardiac biomarkers - NT-pro-BNP

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

    Time frame: 4-6 hours after termination of swimming

Secondary outcomes

  1. 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.

    Time frame: within 12 months after swimming

  2. Baseline Electrocardiogram (ECG) - Rytm analysis

    12-lead Electrocardiogram (ECG). Examination at rest. Rytm analysis and frequency (beats per minute)

    Time frame: within 12 months after swimming

  3. Baseline Electrocardiogram (ECG)- Heart axis

    12-lead Electrocardiogram (ECG). Examination at rest. Assessment of QRS-axis (degrees)

    Time frame: within 12 months after swimming

  4. 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)

    Time frame: within 12 months after swimming

  5. Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia

    12-lead Electrocardiogram (ECG). Examination at rest. ST-elevation, ST-depression, T-wave inversion, Q wave.

    Time frame: within 12 months after swimming

  6. Baseline cardiac biomarkers - Troponin I

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

    Time frame: within 12 months after swimming

  7. Baseline cardiac biomarkers - NT-pro-BNP

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

    Time frame: within 12 months after swimming

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 2026→Dec 2027
Oct 5, 2026
Study completion
Dec 2026→Dec 2027
Oct 5, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 42431395 ↗
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 42431395 ↗
    Primary completion Dec 2026→Dec 2027
    Study completion Dec 2026→Dec 2027
    + 3 other changes: index terms, verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05391737
Lead sponsor
Dalarna County Council, Sweden
Responsible party
Maria Hårdstedt (Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine, Dalarna County Council, Sweden) — Principal investigator
First posted
May 26, 2022
Start date
Jul 6, 2022
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 5, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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