Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Hjertefunksjon ved svømmeindusert lungeødem (SIPE)

30. september 2026 oppdatert av: Maria Hårdstedt, Dalarna County Council, Sweden

Hjertefunksjon ved svømming-indusert lungeødem (SIPE) - en kasuskontrollstudie

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.

Studieoversikt

Detaljert beskrivelse

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).

Studietype

Observasjonsmessig

Registrering (Antatt)

120

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_CONTROL
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.

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

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

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.

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

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acute Echocardiography
Tidsramme: 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.

within 4 hours after termination of swimming
Acute Electrocardiogram (ECG) - Rytm analysis
Tidsramme: within 4 hours after termination of swimming

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

within 4 hours after termination of swimming
Acute Electrocardiogram (ECG) - Heart axis
Tidsramme: within 4 hours after termination of swimming

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

within 4 hours after termination of swimming
Acute Electrocardiogram (ECG) - Amplitudes and intervals
Tidsramme: 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)

within 4 hours after termination of swimming
Acute Electrocardiogram (ECG) - Signs of myocardial ischemia
Tidsramme: within 4 hours after termination of swimming

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
Tidsramme: 4-6 hours after termination of swimming

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

4-6 hours after termination of swimming
Acute cardiac biomarkers - NT-pro-BNP
Tidsramme: 4-6 hours after termination of swimming

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

4-6 hours after termination of swimming

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline Echocardiography
Tidsramme: 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.

within 12 months after swimming
Baseline Electrocardiogram (ECG) - Rytm analysis
Tidsramme: within 12 months after swimming

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

within 12 months after swimming
Baseline Electrocardiogram (ECG)- Heart axis
Tidsramme: within 12 months after swimming

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

within 12 months after swimming
Baseline Electrocardiogram (ECG) - Amplitudes and intervals
Tidsramme: 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)

within 12 months after swimming
Baseline Electrocardiogram (ECG) - Signs of myocardial ischemia
Tidsramme: within 12 months after swimming

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

within 12 months after swimming
Baseline cardiac biomarkers - Troponin I
Tidsramme: within 12 months after swimming

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

within 12 months after swimming
Baseline cardiac biomarkers - NT-pro-BNP
Tidsramme: within 12 months after swimming

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

within 12 months after swimming

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

6. juli 2022

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

17. mai 2022

Først innsendt som oppfylte QC-kriteriene

20. mai 2022

Først lagt ut (Faktiske)

26. mai 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere