Cardiac Function in Swimming-Induced Pulmonary Edema (SIPE)

NCT05391737 | Recruiting

• 1 other identifier: SIPE Cardiac function 001
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Echocardiography; Electrocardiography; Troponin

Outcome Measures

Primary Outcomes (7)

• 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.

  within 4 hours after termination of swimming

• Acute Electrocardiogram (ECG) - Rytm analysis

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

  within 4 hours after termination of swimming

• Acute Electrocardiogram (ECG) - Heart axis

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

  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)

  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.

  within 4 hours after termination of swimming

• Acute cardiac biomarkers - Troponin I

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

  4-6 hours after termination of swimming

• Acute cardiac biomarkers - NT-pro-BNP

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

  4-6 hours after termination of swimming

Secondary Outcomes (7)

• Baseline Echocardiography

  within 12 months after swimming

• Baseline Electrocardiogram (ECG) - Rytm analysis

  within 12 months after swimming

• Baseline Electrocardiogram (ECG)- Heart axis

  within 12 months after swimming

• Baseline Electrocardiogram (ECG) - Amplitudes and intervals

  within 12 months after swimming

• Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia

  within 12 months after swimming

Study Arms (2)

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

Echocardiography DIAGNOSTIC_TEST

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

control group; patients with SIPE

Electrocardiogram (ECG) DIAGNOSTIC_TEST

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

control group; patients with SIPE

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)

control group; patients with SIPE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• declined consent
• hemodynamic instability or decreased consciousness

Sponsors & Collaborators

• Dalarna County Council, Sweden: lead

Study Sites (1)

Center of Clinical Research Dalarna

Falun, 79182, Sweden

RECRUITING

MeSH Terms

Conditions

Pulmonary Edema; Lung Diseases

Interventions

Echocardiography; Electrocardiography

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Maria Hårdstedt, PhD, Specialist Internal Medicine

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 26, 2022
• Study Start: July 6, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)