Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorIRCCS SYNLAB SDN
About this trial
RIGHT-NET 2.0 is a multicenter observational study with a retrospective-prospective design that builds on the original RIGHT-NET study. It aims to observe and document the functional status of the right heart-pulmonary circulation unit (RH-PCU) at rest and during exercise stress transthoracic echocardiography (ExTTE) in clinically stable patients referred to cardiology, internal medicine, echocardiography, and exercise testing laboratories. The study will also include healthy volunteers, individuals with cardiovascular risk factors but no overt disease, athletes undergoing sports eligibility evaluation, and healthy individuals living at high altitude. Patients will be classified according to the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. The study plans to enroll at least 1000 additional subjects beyond the original RIGHT-NET cohort of 1000 participants, for a total anticipated enrollment of approximately 2000 subjects across 22 Italian and 16 international centers. Data will be collected through the REDCap electronic data capture platform in a pseudonymized format.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients referred as part of their routine clinical pathway for evaluation in cardiology, internal medicine, echocardiography, or exercise testing laboratories, with a documented clinical indication for assessment of right heart-pulmonary circulation unit function, as determined by the referring physician
Classified according to the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension
Healthy volunteers, including individuals undergoing occupational fitness assessment
Individuals with cardiovascular risk factors but no overt cardiopulmonary disease
Disqualifiers
Active oncological disease
Clinical conditions incompatible with the execution of exercise stress echocardiography (e.g., inability to perform physical exercise, severe musculoskeletal limitations, unstable angina, recent acute myocardial infarction, uncontrolled arrhythmias)
Current pregnancy
Any other condition judged by the referring physician to be incompatible with participation in the study
Trial population
Patients referred, as part of their routine clinical pathway, to cardiology, internal medicine, echocardiography, or exercise testing (ergometry) laboratories at the participating centers, selected based on a documented clinical indication for right heart-pulmonary circulation unit assessment as determined by the referring physician, and classified according to the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. The population also includes healthy volunteers, including individuals undergoing occupational fitness assessment; individuals with cardiovascular risk factors but no overt cardiopulmonary disease; athletes referred for sports eligibility evaluation; and healthy individuals living at high altitude.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 5 trial groupsGroup A: Patients with Clinical Indication for RH-PCU Assessment
Group B: Healthy Volunteers
Group C: Subjects with Cardiovascular Risk Factors
Group D: Athletes Undergoing Sports Eligibility Evaluation
Group E: Healthy Subjects Living at High Altitude
Trial outcomes
Primary outcomes
1
TAPSE/sPAP ratio at rest and during exercise stress echocardiography
Tricuspid annular plane systolic excursion / systolic pulmonary artery pressure (TAPSE/sPAP) ratio, calculated by resting nd during exercise stress echocardiography as a non-invasive index of right ventricular-pulmonary arterial coupling.
Time frame
Baseline2
mPAP/CO slope at rest and during exercise stress echocardiography
Slope of the relationship between mean pulmonary artery pressure (mPAP) and cardiac output (CO), derived at rest and during incremental exercise stress echocardiography as a non-invasive index of pulmonary vascular function.
Time frame
BaselineSecondary outcomes
1
Incidence of the composite outcome of all-cause mortality or hospitalization for heart failure at follow-up
Number of participants experiencing the composite outcome of death from any cause or hospitalization for left or right heart failure, analyzed in relation to baseline right heart-pulmonary circulation unit (RH-PCU) functional indices.
Time frame
1 year2
Area under the ROC curve (AUC) of the TAPSE/sPAP ratio for predicting the composite outcome of all-cause mortality or hospitalization for heart failure, compared with 2022 ESC/ERS Guideline risk-stratification thresholds
Receiver operating characteristic (ROC) curve analysis of the resting TAPSE/sPAP ratio, assessing its diagnostic and prognostic discriminative ability for the long-term composite outcome (Outcome 3), and refinement of cut-off values relative to the risk-stratification thresholds defined in the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.
Time frame
1 Year3
Area under the ROC curve (AUC) of the mPAP/CO slope for predicting the composite outcome of all-cause mortality or hospitalization for heart failure, compared with 2022 ESC/ERS Guideline risk-stratification thresholds
Receiver operating characteristic (ROC) curve analysis of the mPAP/CO slope during exercise stress echocardiography, assessing its diagnostic and prognostic discriminative ability for the long-term composite outcome (Outcome 3), and refinement of cut-off values relative to the risk-stratification thresholds defined in the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension.
Time frame
1 YearLocations
Sponsors and contacts
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IRCCS SYNLAB SDN
Lead sponsor
University of Pisa
Collaborator
Institute of Clinical Physiology, CNR, Pisa
Collaborator
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborator
University of Milan
Collaborator
IRCCS Multimedica
Collaborator
University Of Perugia
Collaborator
ASST Grande Ospedale Metropolitano Niguarda
Collaborator
IRCCS Ospedale San Raffaele
Collaborator
University of Padova
Collaborator
Federico II University
Collaborator
University of Molise
Collaborator
University of Trieste
Collaborator
Medical University of Graz
Collaborator
Ohio State University
Collaborator
Jewish General Hospital (Montreal, Quebec, Canada)
Collaborator
Universitat Politècnica de Catalunya
Collaborator
University Hospital Heidelberg
Collaborator
Institute of Family Medicine, University of Szeged, Hungary
Collaborator
Medical University of Lodz
Collaborator
Cardio-Thoracic-Vascular Department. University Hospital San Giovanni di Dio e Ruggi d'Aragona. Salerno
Collaborator
CRO "Centro Clinical Trials" IRCCS Ospedale Policlinico San Martino
Collaborator
Umberto I Hospital, Nocera Inferiore
Collaborator
Azienda Sanitaria Universitaria Friuli Centrale
Collaborator
Cardarelli Hospital
Collaborator
Azienda Ospedaliera dei Colli
Collaborator
Source ClinicalTrials.gov
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