Right Heart and Lung Blood Flow During Exercise (RIGHT-NET 2.0) (RIGHT-NET 2)
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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Anna D'Agostino, PhD
- Telefonnummer: +39 345 355 6702
- E-post: anna.dagostino@synlab.it
Studera Kontakt Backup
- Namn: Mario Zanfardino, PhD
- Telefonnummer: +39 345 355 6702
- E-post: mario.zanfardino@synlab.it
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: OTHER
Kohorter och interventioner
Grupp / Kohort |
|---|
|
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
TAPSE/sPAP ratio at rest and during exercise stress echocardiography
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of the composite outcome of all-cause mortality or hospitalization for heart failure at follow-up
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Marco Salvatore, MD,PhD, IRCCS SYNLAB SDN
Publikationer och användbara länkar
Allmänna publikationer
- Humbert M, Kovacs G, Hoeper MM, Badagliacca R, Berger RMF, Brida M, Carlsen J, Coats AJS, Escribano-Subias P, Ferrari P, Ferreira DS, Ghofrani HA, Giannakoulas G, Kiely DG, Mayer E, Meszaros G, Nagavci B, Olsson KM, Pepke-Zaba J, Quint JK, Radegran G, Simonneau G, Sitbon O, Tonia T, Toshner M, Vachiery JL, Vonk Noordegraaf A, Delcroix M, Rosenkranz S; ESC/ERS Scientific Document Group. 2022 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2023 Jan 6;61(1):2200879. doi: 10.1183/13993003.00879-2022. Print 2023 Jan. No abstract available.
- Gargani L, Pugliese NR, De Biase N, Mazzola M, Agoston G, Arcopinto M, Argiento P, Armstrong WF, Bandera F, Cademartiri F, Carbone A, Castaldo R, Citro R, Cocchia R, Codullo V, D'Alto M, D'Andrea A, Douschan P, Fabiani I, Ferrara F, Franzese M, Frumento P, Ghio S, Grunig E, Guazzi M, Kasprzak JD, Kolias T, Kovacs G, La Gerche A, Limogelli G, Marra AM, Matucci-Cerinic M, Mauro C, Moreo A, Pratali L, Ranieri B, Rega S, Rudski L, Saggar R, Salzano A, Serra W, Stanziola AA, Vannan MA, Voilliot D, Vriz O, Wierzbowska-Drabik K, Cittadini A, Naeije R, Bossone E; RIGHT Heart International NETwork (RIGHT-NET) Investigators. Exercise Stress Echocardiography of the Right Ventricle and Pulmonary Circulation. J Am Coll Cardiol. 2023 Nov 21;82(21):1973-1985. doi: 10.1016/j.jacc.2023.09.807.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
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