Health TrialsbyHealthPanel

Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

ConditionsSwimming Induced Pulmonary Edema (SIPE)Pulmonary EdemaLung DiseasesHeart Function Tests
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDalarna County Council, Sweden

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

declined consent

hemodynamic instability or decreased consciousness

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Echocardiography

    Diagnostic test

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

  • Electrocardiogram (ECG)

    Diagnostic test

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

  • Cardiac biomarkers

    Diagnostic test

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: patients with SIPE3 interventions
Group B: control group3 interventions

Trial outcomes

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dalarna County Council, Sweden

Lead sponsor

Source ClinicalTrials.gov
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