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Not Yet Recruiting NCT07851610

Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0)

Conditions: Right Ventricular Dysfunction, Cardiopulmonary Diseases, Pulmonary Hypertension

Sex: All
Healthy volunteers: Yes
Enrollment: 2000
Sponsor: IRCCS SYNLAB SDN

Summary

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

Inclusion Criteria * 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 * Athletes referred for sports eligibility evaluation * Healthy individuals living at high altitude * Clinically stable at the time of enrollment * Provision of consent to the processing of personal data in anonymous and aggregated form Exclusion Criteria * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07851610). StuddyBuddy aggregates publicly available trial information.