[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658477":3},{"organization":4,"outcomesModule":7,"designInfo":105,"detailedDescription":109,"studyPopulation":110,"armGroups":111,"interventions":117,"overallOfficials":106,"centralContacts":123,"locations":132,"responsibleParty":148,"collaborators":152,"id":155,"slug":156,"hasResults":157,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":157,"sex":163,"minAge":164,"maxAge":106,"enrollmentInfo":165,"targetDuration":168,"studyType":169,"phases":106,"briefSummary":170,"conditions":171,"keywords":174,"overallStatus":135,"whyStopped":106,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":196,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},{"fullName":5,"class":6},"Chinese Pulmonary Vascular Disease Research Group","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":96},[9,13],{"measure":10,"description":11,"timeFrame":12},"Prevalence and phenotypic distribution of sleep-disordered breathing and nocturnal hypoxemia","Proportion of participants with sleep-disordered breathing (SDB) and its phenotypes, including obstructive sleep apnea (OSA) and central sleep apnea (CSA), together with the distribution of nocturnal hypoxemia and multidimensional sleep physiological burden. Core measures will include the apnea-hypopnea index (AHI) or respiratory event index (REI), obstructive and central respiratory event indices, oxygen desaturation index (ODI), percentage of recording time with peripheral oxygen saturation below 90% (T90), mean and minimum peripheral oxygen saturation (SpO₂), and prespecified hypoxic-burden metrics. Prevalence estimates will be reported with 95% confidence intervals.","Baseline",{"measure":14,"description":15,"timeFrame":16},"Time to first clinical worsening event","Time from enrollment to the first adjudicated clinical worsening event. The primary composite is recommended to include all-cause death, lung or heart-lung transplantation, PAH-related unplanned hospitalization, atrial septostomy, or clinically driven major PAH treatment escalation\u002Frescue therapy because of documented disease worsening. A sensitivity definition limited to hard outcomes will also be analyzed.","From enrollment through 5 years of follow-up",[18,21,24,27,31,34,38,41,44,48,51,54,57,60,64,68,71,74,77,80,83,86,90,93],{"measure":19,"description":20,"timeFrame":16},"All-cause mortality","Time from enrollment to death from any cause",{"measure":22,"description":23,"timeFrame":16},"Transplant-free survival","Time to death or lung\u002Fheart-lung transplantation",{"measure":25,"description":26,"timeFrame":16},"PAH-related hospitalization","Time to first PAH-related unplanned hospitalization and recurrent hospitalization burden",{"measure":28,"description":29,"timeFrame":30},"Change From Baseline in REVEAL 2.0 Risk Score","The REVEAL 2.0 risk score will be calculated using available clinical variables according to the established REVEAL 2.0 algorithm. Higher scores indicate greater predicted mortality risk. Change from baseline will be evaluated at available follow-up assessments.","Baseline to longitudinal follow-up through 5 years",{"measure":32,"description":33,"timeFrame":30},"Change From Baseline in ESC\u002FERS Four-Strata Risk Status","PAH risk status will be assessed using the ESC\u002FERS four-strata risk assessment approach and classified as low risk, intermediate-low risk, intermediate-high risk, or high risk. For longitudinal analyses, the four categories will be coded ordinally from 1 to 4, with higher values indicating greater estimated risk. Changes from baseline will be assessed during follow-up.",{"measure":35,"description":36,"timeFrame":37},"Change From Baseline in WHO Functional Class","WHO functional class will be assessed according to the World Health Organization functional classification for pulmonary hypertension, ranging from Class I to Class IV. A higher class indicates greater functional limitation.","Baseline to 3-6 months, 12 months, and annual follow-up through 5 years.",{"measure":39,"description":40,"timeFrame":37},"Change From Baseline in 6-Minute Walk Distance","Exercise capacity will be assessed using the 6-minute walk distance performed according to standardized clinical procedures. Change from baseline in walking distance will be evaluated during follow-up.",{"measure":42,"description":43,"timeFrame":37},"Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide","Plasma N-terminal pro-B-type natriuretic peptide concentration will be recorded when measured as part of routine clinical assessment. Change from baseline will be evaluated at available follow-up assessments.",{"measure":45,"description":46,"timeFrame":47},"Change From Baseline in Right Atrial Pressure","Right atrial pressure will be measured by right-heart catheterization. Longitudinal change will be evaluated in participants who undergo clinically indicated repeat right-heart catheterization.","Baseline to repeat right-heart catheterization during follow-up, up to 5 years",{"measure":49,"description":50,"timeFrame":47},"Change From Baseline in Mean Pulmonary Artery Pressure","Mean pulmonary artery pressure will be measured by right-heart catheterization. Longitudinal change will be evaluated when repeat right-heart catheterization data are available.",{"measure":52,"description":53,"timeFrame":47},"Change From Baseline in Pulmonary Arterial Wedge Pressure","Pulmonary arterial wedge pressure will be measured during right-heart catheterization.",{"measure":55,"description":56,"timeFrame":47},"Change From Baseline in Cardiac Index","Cardiac output will be determined during right-heart catheterization according to the standardized method used at the participating center. Cardiac index will be calculated as cardiac output indexed to body surface area.",{"measure":58,"description":59,"timeFrame":47},"Change From Baseline in Pulmonary Vascular Resistance","Pulmonary vascular resistance will be calculated from invasive hemodynamic measurements obtained during right-heart catheterization.",{"measure":61,"description":62,"timeFrame":63},"Change From Baseline in Respiratory Event Index","Respiratory event index will be calculated as the number of scored respiratory events per hour of valid recording time in participants assessed using portable cardiorespiratory monitoring.","Baseline to repeat sleep monitoring during follow-up, up to 5 years",{"measure":65,"description":66,"timeFrame":67},"Change From Baseline in Apnea-Hypopnea Index","Apnea-hypopnea index will be calculated as the number of apneas and hypopneas per hour of total sleep time in participants undergoing polysomnography.","Baseline to repeat polysomnography during follow-up, up to 5 years",{"measure":69,"description":70,"timeFrame":63},"Change From Baseline in Oxygen Desaturation Index","Oxygen desaturation index will be calculated as the number of qualifying oxygen desaturation events per hour of valid recording time according to the prespecified scoring criteria.",{"measure":72,"description":73,"timeFrame":63},"Change From Baseline in Percentage of Recording Time With Oxygen Saturation Below 90% (T90)","T90 will be defined as the percentage of valid overnight recording time during which peripheral oxygen saturation is below 90%.",{"measure":75,"description":76,"timeFrame":63},"Change From Baseline in Mean Overnight Oxygen Saturation","Mean peripheral oxygen saturation will be calculated across the valid overnight recording period.",{"measure":78,"description":79,"timeFrame":63},"Change From Baseline in Minimum Overnight Oxygen Saturation","Minimum peripheral oxygen saturation will be defined as the lowest valid oxygen saturation value recorded during the overnight monitoring period after signal-quality control.",{"measure":81,"description":82,"timeFrame":63},"Change From Baseline in Respiratory Event-Associated Hypoxic Burden","Respiratory event-associated hypoxic burden will quantify the cumulative area under oxygen desaturation curves associated with scored respiratory events, normalized by recording duration.",{"measure":84,"description":85,"timeFrame":63},"Change From Baseline in Mean Event-Related Heart-Rate Surge","Event-related heart-rate surge will be calculated as the increase from the pre-event heart-rate baseline to the post-event peak heart rate for each qualifying respiratory event. The participant-level mean event-related heart-rate surge will be used for longitudinal analysis.",{"measure":87,"description":88,"timeFrame":89},"Change From Baseline in Tricuspid Annular Plane Systolic Excursion","Tricuspid annular plane systolic excursion (TAPSE) will be measured by echocardiography as an index of right ventricular longitudinal systolic function. Change from baseline will be evaluated during longitudinal follow-up.","Baseline to annual follow-up through 5 years.",{"measure":91,"description":92,"timeFrame":89},"Change From Baseline in Right Ventricular Fractional Area Change","Right ventricular fractional area change (RV FAC) will be assessed by echocardiography as an index of right ventricular systolic function. Change from baseline will be evaluated during longitudinal follow-up.",{"measure":94,"description":95,"timeFrame":89},"Change From Baseline in TAPSE\u002FsPAP Ratio","The ratio of tricuspid annular plane systolic excursion to systolic pulmonary artery pressure (TAPSE\u002FsPAP) will be calculated from echocardiographic measurements as a noninvasive marker of right ventricular-pulmonary arterial coupling. Change from baseline will be evaluated during longitudinal follow-up.",[97,101],{"measure":98,"description":99,"timeFrame":100},"Predictive Performance of AI-Enabled Multimodal Models for Major Clinical Worsening","Artificial intelligence and machine-learning approaches will be used to derive data-driven nocturnal physiological phenotypes and to develop multimodal prediction models integrating sleep-derived signals with clinical, hemodynamic, imaging, electrocardiographic, and laboratory variables. Predictive performance for the primary longitudinal outcome of major clinical worsening will be evaluated using the area under the receiver operating characteristic curve (AUROC) in held-out or center-level validation datasets.","From baseline assessment through 5 years of follow-up.",{"measure":102,"description":103,"timeFrame":104},"Treatment-Response Heterogeneity According to Baseline Sleep Phenotype","Treatment response will be evaluated according to baseline sleep-disordered breathing and nocturnal physiological phenotype. A clinically meaningful response will be defined as improvement by at least one category in the ESC\u002FERS four-strata PAH risk classification following initiation or escalation of PAH-targeted therapy. The proportion of participants achieving this predefined response will be compared across baseline sleep phenotypes. Analyses will account for treatment regimen, baseline disease severity, and other relevant confounders.","From treatment initiation or escalation to the subsequent clinical reassessment, generally within 3-12 months, and through 5 years of follow-up.",{"allocation":106,"interventionModel":106,"interventionModelDescription":106,"primaryPurpose":106,"observationalModel":107,"timePerspective":108,"maskingInfo":106},null,"COHORT","PROSPECTIVE","PAH-SDB is designed as a disease-based prospective multicenter patient registry and longitudinal cohort. The registry addresses the interaction between sleep-disordered breathing (SDB) or nocturnal respiratory physiology and pulmonary vascular disease across the contemporary treatment era of pulmonary arterial hypertension (PAH). The study is intentionally broader than an apnea-hypopnea-index-centered cohort and will capture obstructive and central respiratory events, sustained and intermittent hypoxemia, desaturation morphology and burden, heart-rate and autonomic responses, respiratory instability, sleep fragmentation when available, and other digital physiological features derived from validated sleep or wearable devices.\n\nEligible participants will have WHO Group 1 PAH confirmed by right heart catheterization using contemporary hemodynamic criteria. Baseline assessment will include PAH etiology and duration, comorbidities, symptoms and WHO functional class, six-minute walk distance, natriuretic peptides and routine laboratory tests, electrocardiography, echocardiography, right-heart-catheterization variables, PAH-specific therapies, oxygen and positive-airway-pressure use, patient-reported outcomes where feasible, and a standardized overnight sleep study. The core sleep protocol will include airflow, respiratory effort, pulse oximetry, heart rate or electrocardiographic information, body position, and snoring when supported by the device. Full polysomnography will be performed in a nested subgroup according to clinical indication, center capability, or dedicated substudy protocols.\n\nParticipants will be followed longitudinally for clinical worsening, PAH-related hospitalization, therapy escalation, lung or heart-lung transplantation, and mortality. Repeated PAH assessments will be obtained according to routine clinical care, with harmonized registry time points. Repeat sleep monitoring is planned in a longitudinal subset, particularly after major changes in PAH treatment, clinically meaningful change in disease status, or initiation of sleep-related therapy. The registry will therefore support both baseline phenotype-outcome analyses and analyses of dynamic change.\n\nMajor scientific objectives are: (1) to determine the prevalence and distribution of sleep-disordered breathing and nocturnal hypoxemia in contemporary Chinese PAH; (2) to identify demographic, clinical, hemodynamic, imaging, and treatment correlates of nocturnal physiological phenotypes; (3) to quantify associations between sleep metrics and PAH severity, right ventricular structure and function, and validated risk strata; (4) to determine the incremental prognostic value of nocturnal physiological markers beyond established PAH risk tools; (5) to evaluate whether changes in sleep physiology track or precede changes in PAH status and treatment response; (6) to explore heterogeneity of associations across PAH subtypes, sex, age, body mass index, comorbidity burden, and treatment patterns; and (7) to develop and externally validate multimodal machine-learning and artificial-intelligence models for physiological endotyping, risk prediction, and individualized clinical decision support.\n\nRegistry quality procedures will include a standardized electronic case-report form, a data dictionary, investigator training, site initiation procedures, automated range and consistency checks, centralized data queries, periodic completeness reports, prespecified sleep-signal quality criteria, central or centrally supervised sleep scoring for key analyses, and adjudication of major clinical worsening events. A statistical analysis plan will be finalized before primary analyses. Conventional regression and time-to-event methods will be complemented by longitudinal mixed-effects models, internal-external validation across sites, causal-inference approaches for treatment-response analyses when appropriate, and multimodal machine-learning methods. Missing data mechanisms will be documented and addressed using prespecified statistical methods.\n\nThe registry is non-interventional. PAH therapy, oxygen therapy, positive airway pressure, and other clinical management will be prescribed by treating clinicians according to clinical judgment and prevailing guidelines. Any future substudy that prospectively assigns an intervention will be governed by a separate protocol and registered separately when required.","Consecutive adult patients with RHC-confirmed WHO Group 1 PAH receiving care at participating pulmonary vascular and cardiovascular centers in China. The registry will include newly diagnosed and prevalent PAH, with enrollment strata defined by disease duration and treatment status. Participating centers will include Fuwai Hospital and additional Chinese centers with expertise in PAH and the ability to perform standardized clinical and nocturnal physiological assessments.",[112],{"label":113,"type":106,"description":114,"interventionNames":115},"PAH-SDB Prospective Cohort","Adults with right-heart catheterization (RHC)-confirmed WHO Group 1 pulmonary arterial hypertension (PAH) consecutively enrolled at participating Chinese centers and followed prospectively with standardized nocturnal sleep\u002Fcardiorespiratory phenotyping and longitudinal PAH assessments.",[116],"Diagnostic Test: Standardized Overnight Sleep and Cardiorespiratory Monitoring",[118],{"type":119,"name":120,"description":121,"armGroupLabels":122,"otherNames":106},"DIAGNOSTIC_TEST","Standardized Overnight Sleep and Cardiorespiratory Monitoring","Participants undergo protocol-standardized nocturnal monitoring without study-assigned therapy. The core recording includes airflow, respiratory effort, oxygen saturation, pulse\u002Fheart rate, body position, and snoring when available. Full polysomnography, extended wearable monitoring, repeated sleep studies, and other physiological signals may be obtained in nested subcohorts. All sleep-related treatment decisions remain under routine clinical care.",[113],[124,129],{"name":125,"role":126,"phone":127,"phoneExt":106,"email":128},"Zhihong Liu, MD, PhD","CONTACT","86-010-88398196","zhihongliufuwai@163.com",{"name":130,"role":126,"phone":106,"phoneExt":106,"email":131},"Zhihua Huang, MD, PhD","huangzhihua@fuwai.com",[133],{"facility":134,"status":135,"city":136,"state":106,"zip":137,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":146},"Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College","RECRUITING","Beijing","100037","China","CN",{"type":141,"coordinates":142},"Point",[143,144],116.39723,39.9075,{"lat":144,"lon":143},[147],{"name":125,"role":126,"phone":127,"phoneExt":106,"email":128},{"type":149,"investigatorFullName":150,"investigatorTitle":151,"investigatorAffiliation":5,"oldNameTitle":106,"oldOrganization":106},"PRINCIPAL_INVESTIGATOR","Zhihong Liu","Director",[153],{"name":154,"class":6},"Chinese Academy of Medical Sciences, Fuwai Hospital","100658477","pah-sdb-sleep-disordered-breathing-and-outcomes-in-pulmonary-arterial-hypertension-100658477",false,"NCT07852403","PAH-SDB: Sleep-Disordered Breathing and Outcomes in Pulmonary Arterial Hypertension","PAH-SDB: A Prospective Multicenter Cohort Study of Sleep-Disordered Breathing, Nocturnal Physiological Phenotypes, and Longitudinal Outcomes in Pulmonary Arterial Hypertension","PAH-SDB","Inclusion Criteria:\n\n* Age ≥18 years at enrollment.\n* Diagnosis of WHO Group 1 pulmonary arterial hypertension established by right heart catheterization using contemporary hemodynamic criteria: mean pulmonary artery pressure \\>20 mmHg at rest, pulmonary arterial wedge pressure ≤15 mmHg, and pulmonary vascular resistance \\>2 Wood units, with clinical classification consistent with Group 1 PAH.\n* PAH etiology may include idiopathic, heritable, drug\u002Ftoxin-associated, connective-tissue-disease-associated, congenital-heart-disease-associated PAH after appropriate clinical classification, portal-hypertension-associated PAH, HIV-associated PAH, or other recognized Group 1 PAH subtypes.\n* Clinically stable enough to undergo overnight sleep\u002Fcardiorespiratory monitoring, as judged by the treating team.\n* Able and willing to provide written informed consent and participate in longitudinal follow-up.\n* Enrollment at a participating center with availability of the required baseline PAH dataset and a technically interpretable protocol-standardized sleep recording.\n\nExclusion Criteria:\n\n* Pulmonary hypertension predominantly attributable to left heart disease (Group 2), lung disease and\u002For hypoxia (Group 3), chronic thromboembolic pulmonary hypertension or other pulmonary artery obstruction (Group 4), or unclear\u002Fmultifactorial mechanisms (Group 5).\n* Pulmonary veno-occlusive disease \u002F pulmonary capillary hemangiomatosis when the clinical phenotype is considered separately from conventional PAH for the planned analysis, unless the protocol intentionally includes this subgroup and prespecifies it as a distinct stratum.\n* Acute decompensated right heart failure, cardiogenic shock, severe active infection, or another acute condition that would make the baseline sleep recording unrepresentative or unsafe; these patients may be reconsidered after stabilization.\n* Current hospitalization primarily for an acute non-PAH illness likely to substantially distort nocturnal respiratory physiology.\n* Inability to obtain an adequate baseline sleep\u002Fcardiorespiratory recording after protocol-defined repeat attempt, unless the participant is retained in a registry-only stratum for non-sleep analyses.\n* Inability to provide informed consent or anticipated inability to complete meaningful follow-up.\n* Any other condition that, in the investigator's judgment, would prevent reliable study participation or data interpretation.","ALL","18 Years",{"count":166,"type":167},1500,"ESTIMATED","5 Years","OBSERVATIONAL","Pulmonary arterial hypertension (PAH) is a progressive pulmonary vascular disease characterized by increased pulmonary vascular resistance, right ventricular dysfunction, and clinically important morbidity and mortality. Sleep-disordered breathing (SDB) and sleep-related hypoxemia are common in patients with PAH, but their prevalence, physiological determinants, longitudinal trajectories, prognostic significance, and potential role in individualized management remain incompletely defined.\n\nPAH-SDB is a prospective, multicenter, observational patient registry enrolling adults with right-heart-catheterization-confirmed World Health Organization Group 1 PAH at pulmonary vascular centers across China. Participants will undergo standardized nocturnal sleep and cardiorespiratory monitoring together with comprehensive PAH assessment, including clinical characteristics, functional status, biomarkers, echocardiography, hemodynamics, treatment, and outcomes. Selected participants may undergo additional polysomnography, cardiac magnetic resonance imaging, wearable monitoring, repeated sleep assessments, or biospecimen collection when available and ethically approved.\n\nThe registry will characterize the prevalence and phenotypes of sleep-disordered breathing and nocturnal physiological abnormalities; examine their relationships with PAH severity and right ventricular-pulmonary vascular function; determine their value for predicting clinical worsening, hospitalization, transplantation, and mortality; evaluate longitudinal changes in sleep physiology in relation to PAH treatment and disease trajectory; and develop and validate multimodal statistical and artificial-intelligence models for phenotyping, risk prediction, and treatment-response stratification. Clinical management will remain at the discretion of treating physicians, and the registry will not assign PAH or sleep-related therapies.",[172,173],"Pulmonary Arterial Hypertension (PAH)","Sleep-disordered Breathing (SDB)",[175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191],"Pulmonary arterial hypertension","sleep apnea","obstructive sleep apnea","central sleep apnea","nocturnal hypoxemia","hypoxic burden","oxygen desaturation","right ventricular function","right heart catheterization","risk stratification","clinical worsening","real-world evidence","digital biomarkers","wearable devices","artificial intelligence","machine learning","precision medicine","2026-09-30",{"date":194,"type":195},"2026-10-01","ACTUAL",{"date":194,"type":167},{"date":198,"type":167},"2032-12-31",{"name":5,"class":6},1]