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Right Heart International NETwork During Exercise in Different Clinical Conditions (RIGHT-Net)

31. januar 2017 oppdatert av: Eduardo Bossone, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Morphological and Functional Response of the Right Heart and Pulmonary Circulation

The aim of this registry will be to compare the pathophysiological response of the morphology and function of the right heart and pulmonary circulation assessed with resting and stress-echocardiography in patients with various cardiovascular diseases, to compare them to healthy individuals. The physiological response in healthy individuals as well as elite athletes, defined as athletes participating at national and international competitions, will also be evaluated. Patients will be enrolled both prospectively as well as retrospectively and the will be evaluated by resting and stress echocardiography, which are part of the routine clinical practice.

All clinical outcome measures will be collected as part of routine examinations. The measurements will include systolic and diastolic pump function of the right and left ventricles and other echocardiographic parameters. Moreover, a comparison of these parameters among different groups will be performed. Other optional assessments will include: exercise capacity assessed with 6-minute walking distance, World Health Organization functional class (WHO functional class), peak oxygen uptake assessed by spiroergometry. Patients will be evaluated at baseline and each year with the aforementioned procedures according to the sites clinical routine.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Patients will be evaluated with a routinely performed resting and stress echocardiography. Moreover, physical examination and ECG will be performed and past medical history will be collected. Optional procedures comprise of quality of life assessment (SF-36 questionnaire), six minute walking distance (6MWD), cardiopulmonary exercise testing (CPET), routine laboratory including biochemical work-up.

Comparison among different cohorts of patients with regards to right heart morphology and function at rest, assessed during a routinely performed resting and stress echography. The following parameters will be evaluated:

  • Right ventricular (RV) diameters
  • RV free wall thickness
  • End-diastolic and end-systolic left ventricular volumes and ejection fraction
  • Right atrial (RA) area
  • End-diastolic and end-systolic RV area and % shortening of the areas of the right ventricle
  • Tricuspid regurgitation velocity (TRV) and severity
  • Tricuspid annular plane systolic excursion (TAPSE)
  • Inferior vena cava diameter and % of collapsibility
  • TAPSE at peak exercise and after 5 minutes recovery
  • TRV at peak exercise and after 5 minutes recovery
  • RV end-diastolic and end-systolic area and % shortening of the areas at peak exercise and after 5 minutes recovery
  • RA area at peak exercise and after 5 minutes recovery
  • Left ventricular end-diastolic and end-systolic volume and ejection fraction at peak exercise and after 5 minutes recovery
  • Left ventricular eccentricity index at peak exercise and after 5 minutes recovery

Studietype

Observasjonsmessig

Registrering (Forventet)

1000

Kontakter og plasseringer

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

Studiekontakt

  • Navn: Eduardo Bossone, Chief of Cardiology
  • Telefonnummer: +390899926241
  • E-post: ebossone@hotmail.com

Studer Kontakt Backup

Studiesteder

  • Italia
    • Salerno
      • Cava de' Tirreni, Salerno, Italia, 84019
        • Rekruttering
        • Cardiology and Coronary Care Unit
        • Ta kontakt med:
        • Ta kontakt med:

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 til 99 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients and healthy subjects will be enrolled both retrospectively as well as prospectively.

Beskrivelse

Inclusion Criteria:

  • Written informed consent
  • Males and females ≥ 18 years' old
  • Ability to understand study-specific design and procedures and provide informed consent to the study

Exclusion Criteria:

  • Inability to perform exercise stress test
  • Active smoker
  • Pregnancy and/or lactation
  • Active malignancy
  • End-stage renal disease requiring dialysis

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Healthy subjects
Cohort of patients referred to our echocardiography laboratory to work assessment procedures and without any cardiovascular risk factor. They will underwent stress echocardiography.
Diagnostisk test: stress echocardiography

stress echocardiography will be performed in accordance with the current guidelines on a variable load 45° cycle ergometer with an incremental workload of 25 W every 2 minutes up to the symptom-limited maximal tolerated workload. Echocardiographic measurements will be acquired at baseline, at peak exercise and during recovery of 5 minutes.

The electrocardiogram and blood pressure will be monitored at each workload. Termination criteria and / or positive test criteria for inducible myocardial ischemia will follow the current recommendations
cardio-respiratory diseases
patients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography.
Diagnostisk test: stress echocardiography

stress echocardiography will be performed in accordance with the current guidelines on a variable load 45° cycle ergometer with an incremental workload of 25 W every 2 minutes up to the symptom-limited maximal tolerated workload. Echocardiographic measurements will be acquired at baseline, at peak exercise and during recovery of 5 minutes.

The electrocardiogram and blood pressure will be monitored at each workload. Termination criteria and / or positive test criteria for inducible myocardial ischemia will follow the current recommendations

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Right Ventricle contractile reserve
Tidsramme: ten years
Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)
ten years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-cause Mortality
Tidsramme: ten years
All cause of mortality
ten years
Cardiovascular Mortality
Tidsramme: ten years
all cardiovascular mortality
ten years
RV internal end-diastolic diameters
Tidsramme: ten years
measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm
ten years
tricuspid annular plane systolic excursion (TAPSE)
Tidsramme: ten years
tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm
ten years

Samarbeidspartnere og etterforskere

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

Sponsor

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Etterforskere

  • Studiestol: Eduardo Bossone, Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"

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)

1. juni 2015

Primær fullføring (Forventet)

1. januar 2020

Studiet fullført (Forventet)

1. januar 2025

Datoer for studieregistrering

Først innsendt

25. januar 2017

Først innsendt som oppfylte QC-kriteriene

31. januar 2017

Først lagt ut (Anslag)

2. februar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RIGHT-Net

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. .

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