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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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
Typ studiów
Zapisy (Oczekiwany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Eduardo Bossone, Chief of Cardiology
- Numer telefonu: +390899926241
- E-mail: ebossone@hotmail.com
Kopia zapasowa kontaktu do badania
- Nazwa: Alberto M. Marra, MD
- Numer telefonu: +4915207559254
- E-mail: alberto.marra@med.uni-heidelberg.de
Lokalizacje studiów
-
-
Salerno
-
Cava de' Tirreni, Salerno, Włochy, 84019
- Rekrutacyjny
- Cardiology and Coronary Care Unit
-
Kontakt:
- Eduardo Bossone
- Numer telefonu: +390899926241
- E-mail: ebossone@hotmail.com
-
Kontakt:
- Francesco Ferrara
- Numer telefonu: +393386762554
- E-mail: francesco.ferrara30@tin.it
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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 |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Right Ventricle contractile reserve
Ramy czasowe: ten years
|
Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)
|
ten years
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
All-cause Mortality
Ramy czasowe: ten years
|
All cause of mortality
|
ten years
|
|
Cardiovascular Mortality
Ramy czasowe: ten years
|
all cardiovascular mortality
|
ten years
|
|
RV internal end-diastolic diameters
Ramy czasowe: 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)
Ramy czasowe: ten years
|
tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm
|
ten years
|
Współpracownicy i badacze
Śledczy
- Krzesło do nauki: Eduardo Bossone, Azienda Universitaria Ospedaliera "S. Giovanni e Ruggi d'Aragona"
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- RIGHT-Net
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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