Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

Sponsor
Dalarna County Council, Sweden (Other)
Overall Status
Recruiting
CT.gov ID
NCT05391737
Collaborator
(none)
120
1
52.9
2.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE) - a Case Control Study
Actual Study Start Date :
Jul 6, 2022
Anticipated Primary Completion Date :
Dec 1, 2026
Anticipated Study Completion Date :
Dec 1, 2026

Arms and Interventions

Arm 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)

Outcome Measures

Primary Outcome Measures

  1. Acute Echocardiography [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.

  2. Acute Electrocardiogram (ECG) - Rytm analysis [within 4 hours after termination of swimming]

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

  3. Acute Electrocardiogram (ECG) - Heart axis [within 4 hours after termination of swimming]

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

  4. Acute Electrocardiogram (ECG) - Amplitudes and intervals [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)

  5. Acute Electrocardiogram (ECG) - Signs of myocardial ischemia [within 4 hours after termination of swimming]

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

  6. Acute cardiac biomarkers - Troponin I [4-6 hours after termination of swimming]

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

  7. Acute cardiac biomarkers - NT-pro-BNP [4-6 hours after termination of swimming]

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

Secondary Outcome Measures

  1. Baseline Echocardiography [within 12 months after swimming]

    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.

  2. Baseline Electrocardiogram (ECG) - Rytm analysis [within 12 months after swimming]

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

  3. Baseline Electrocardiogram (ECG)- Heart axis [within 12 months after swimming]

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

  4. Baseline Electrocardiogram (ECG) - Amplitudes and intervals [within 12 months after swimming]

    12-lead Electrocardiogram (ECG). Examination at rest. Duration of PQ-interval (ms), QRS-complex (ms), QT-interval (ms), QRS amplitude (mV)

  5. Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia [within 12 months after swimming]

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

  6. Baseline cardiac biomarkers - Troponin I [within 12 months after swimming]

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

  7. Baseline cardiac biomarkers - NT-pro-BNP [within 12 months after swimming]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center of Clinical Research Dalarna Falun Sweden 79182

Sponsors and Collaborators

  • Dalarna County Council, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maria Hårdstedt, Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine, Dalarna County Council, Sweden
ClinicalTrials.gov Identifier:
NCT05391737
Other Study ID Numbers:
  • SIPE Cardiac function 001
First Posted:
May 26, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maria Hårdstedt, Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine, Dalarna County Council, Sweden
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022