An observational study in Right Ventricular Dysfunction, sponsored by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-02-02.
Sponsored by Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona · Observational
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.
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:
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Patients and healthy subjects will be enrolled both retrospectively as well as prospectively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cohort of patients referred to our echocardiography laboratory to work assessment procedures and without any cardiovascular risk factor. They will underwent stress echocardiography.
Diagnostic Test: stress echocardiography
patients with any possible cardiovascular and respiratory condition. They will underwent stress echocardiography.
Diagnostic 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
Right Ventricle contractile reserve
Difference of tricuspid regurgitation velocity at rest to peak exercise (m/s)
Time frame: ten years
All-cause Mortality
All cause of mortality
Time frame: ten years
Cardiovascular Mortality
all cardiovascular mortality
Time frame: ten years
RV internal end-diastolic diameters
measurement of basal and midcavity RV internal end-diastolic diameters from the four-chamber view in mm
Time frame: ten years
tricuspid annular plane systolic excursion (TAPSE)
tricuspid annular plane systolic excursion (TAPSE) determined in M-mode in mm
Time frame: ten years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona