Right Heart International NETwork During Exercise in Different Clinical Conditions (RIGHT-Net)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienkontakt
- Name: Eduardo Bossone, Chief of Cardiology
- Telefonnummer: +390899926241
- E-Mail: ebossone@hotmail.com
Studieren Sie die Kontaktsicherung
- Name: Alberto M. Marra, MD
- Telefonnummer: +4915207559254
- E-Mail: alberto.marra@med.uni-heidelberg.de
Studienorte
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Salerno
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Cava de' Tirreni, Salerno, Italien, 84019
- Rekrutierung
- Cardiology and Coronary Care Unit
-
Kontakt:
- Eduardo Bossone
- Telefonnummer: +390899926241
- E-Mail: ebossone@hotmail.com
-
Kontakt:
- Francesco Ferrara
- Telefonnummer: +393386762554
- E-Mail: francesco.ferrara30@tin.it
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
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.
|
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.
|
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 |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Right Ventricle contractile reserve
Zeitfenster: ten years
|
Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)
|
ten years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
All-cause Mortality
Zeitfenster: ten years
|
All cause of mortality
|
ten years
|
|
Cardiovascular Mortality
Zeitfenster: ten years
|
all cardiovascular mortality
|
ten years
|
|
RV internal end-diastolic diameters
Zeitfenster: 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)
Zeitfenster: ten years
|
tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm
|
ten years
|
Mitarbeiter und Ermittler
Ermittler
- Studienstuhl: Eduardo Bossone, Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RIGHT-Net
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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