PAH-SDB: A Prospective Multicenter Cohort Study of Sleep-Disordered Breathing, Nocturnal Physiological Phenotypes, and Longitudinal Outcomes in Pulmonary Arterial Hypertension
| Registry | NCT07852403, acronym PAH-SDB |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 1500 (Estimated) |
| Sponsor | Chinese Pulmonary Vascular Disease Research Group (Other); collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital |
| Conditions | Pulmonary Arterial Hypertension (PAH), Sleep-disordered Breathing (SDB) |
| Interventions | Standardized Overnight Sleep and Cardiorespiratory Monitoring (Diagnostic test) |
| Dates | start 2026-10-01 (estimated), primary completion 2031-12-31 (estimated), completion 2032-12-31 (estimated), first posted 2026-10-01, last updated 2026-10-01 |
| Locations | 1 site in China |
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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.
PAH-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.
The 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.
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.
Eligible 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.
Participants 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.
Major 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.
Registry 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.
The 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PAH-SDB Prospective Cohort | Diagnostic Test: Standardized Overnight Sleep and Cardiorespiratory Monitoring | 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/cardiorespiratory phenotyping and longitudinal PAH assessments. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age ≥18 years at enrollment. * 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. * PAH etiology may include idiopathic, heritable, drug/toxin-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. * Clinically stable enough to undergo overnight sleep/cardiorespiratory monitoring, as judged by the treating team. * Able and willing to provide written informed consent and participate in longitudinal follow-up. * Enrollment at a participating center with availability of the required baseline PAH dataset and a technically interpretable protocol-standardized sleep recording. Exclusion Criteria: * Pulmonary hypertension predominantly attributable to left heart disease (Group 2), lung disease and/or hypoxia (Group 3), chronic thromboembolic pulmonary hypertension or other pulmonary artery obstruction (Group 4), or unclear/multifactorial mechanisms (Group 5). * Pulmonary veno-occlusive disease / 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. * 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. * Current hospitalization primarily for an acute non-PAH illness likely to substantially distort nocturnal respiratory physiology. * Inability to obtain an adequate baseline sleep/cardiorespiratory recording after protocol-defined repeat attempt, unless the participant is retained in a registry-only stratum for non-sleep analyses. * Inability to provide informed consent or anticipated inability to complete meaningful follow-up. * Any other condition that, in the investigator's judgment, would prevent reliable study participation or data interpretation.
| Facility | City | Country | Status |
|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | China | Recruiting |