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Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0) (RIGHT-NET 2)

2026年9月25日更新者：Marco Salvatore、IRCCS SYNLAB SDN

The Right Heart International NETwork 2.0 (RIGHT-NET 2.0)

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.

研究概览

地位

尚未招聘

条件

详细说明

The clinical and instrumental assessment of the right heart-pulmonary circulation unit is an essential step in the diagnostic, prognostic, and therapeutic algorithm of cardiorespiratory diseases. The original RIGHT-NET study demonstrated the relevance of physiological versus pathological responses through evaluation of the TAPSE/sPAP ratio and mPAP/CO slope during exercise stress echocardiography, both of which carry prognostic significance and predict all-cause mortality across healthy subjects, athletes, high-altitude residents, and patients with cardiopulmonary disease.

Study objectives include advancing understanding of RH-PCU physiology and pathophysiology during exercise, assessing the discriminative capacity of TAPSE/sPAP and mPAP/CO slope across clinical conditions, investigating associations between RH-PCU functional indices and short-, medium-, and long-term clinical outcomes including all-cause mortality, refining diagnostic and prognostic thresholds in line with the 2022 ESC/ERS guidelines, and building a standardized dataset via REDCap.

For each participant, demographic, anthropometric, and clinical characteristics will be collected, together with laboratory tests, invasive and non-invasive diagnostic procedures (including right heart catheterization, cardiac MRI, nuclear diagnostics, and arterial blood gas analysis), therapy data, and clinical outcomes. Data will be analyzed using R (version >= 4.3.1) with descriptive statistics, group comparisons, univariate and multivariate regression models, and supervised machine learning techniques (random forest, gradient boosting, support vector machine) for predictive modeling.

As an observational study, participation does not alter the participant's diagnostic or therapeutic pathway, and no additional insurance coverage beyond standard clinical practice is required.

研究类型

观察性的

注册 (估计的)

2000

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Anna D'Agostino, PhD
电话号码：‪+39 345 355 6702‬
邮箱：anna.dagostino@synlab.it

研究联系人备份

姓名：Mario Zanfardino, PhD
电话号码：‪+39 345 355 6702‬
邮箱：mario.zanfardino@synlab.it

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：COHORT
时间观点：OTHER

团体/队列数

队列和干预

团体/队列
Patients with Clinical Indication for RH-PCU Assessment Patients referred, as part of their routine clinical pathway, to cardiology, internal medicine, echocardiography, or exercise testing laboratories for evaluation of right heart-pulmonary circulation unit function, based on a documented clinical indication as determined by the referring physician. Patients are classified according to the 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Intervention/exposure of interest: rest and exercise stress transthoracic color-Doppler echocardiography (ExTTE); additional non-invasive and invasive diagnostic procedures (right heart catheterization, cardiac MRI, nuclear diagnostics, arterial blood gas analysis) are performed where clinically indicated, as part of standard care.
Healthy Volunteers Healthy individuals enrolled as volunteers or referred for assessment of fitness for work, with no known cardiopulmonary disease. Intervention/exposure of interest: rest and exercise stress transthoracic echocardiography (ExTTE), performed as part of the study assessment.
Subjects with Cardiovascular Risk Factors Individuals presenting cardiovascular risk factors (e.g. hypertension, dyslipidemia, obesity, diabetes) but without overt cardiovascular or respiratory disease. Intervention/exposure of interest: rest and exercise stress transthoracic echocardiography (ExTTE), performed as part of the study assessment.
Athletes Undergoing Sports Eligibility Evaluation Athletes referred to participating centers for evaluation of fitness for competitive or amateur sports activity. Intervention/exposure of interest: rest and exercise stress transthoracic echocardiography (ExTTE), performed as part of the study assessment.
Healthy Subjects Living at High Altitude Healthy individuals residing at high altitude, included to characterize right heart-pulmonary circulation unit adaptation to chronic hypoxic exposure. Intervention/exposure of interest: rest and exercise stress transthoracic echocardiography (ExTTE), performed as part of the study assessment.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
TAPSE/sPAP ratio at rest and during exercise stress echocardiography 大体时间：Baseline	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.	Baseline
mPAP/CO slope at rest and during exercise stress echocardiography 大体时间：Baseline	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.	Baseline

次要结果测量

结果测量	措施说明	大体时间
Incidence of the composite outcome of all-cause mortality or hospitalization for heart failure at follow-up 大体时间：1 year	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.	1 year
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 大体时间：1 Year	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.	1 Year
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 大体时间：1 Year	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.	1 Year