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PAH-SDB: Sleep-Disordered Breathing and Outcomes in Pulmonary Arterial Hypertension (PAH-SDB)

30 settembre 2026 aggiornato da: Zhihong Liu, Chinese Pulmonary Vascular Disease Research Group

PAH-SDB: A Prospective Multicenter Cohort Study of Sleep-Disordered Breathing, Nocturnal Physiological Phenotypes, and Longitudinal Outcomes in Pulmonary Arterial Hypertension

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

1500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Cina
      • Beijing, Cina, 100037
        • Reclutamento
        • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Modelli osservazionali: COHORT
  • Prospettive temporali: PROSPECTIVE

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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/cardiorespiratory phenotyping and longitudinal PAH assessments.
Test diagnostico: 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/heart 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prevalence and phenotypic distribution of sleep-disordered breathing and nocturnal hypoxemia
Lasso di tempo: Baseline

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
Time to first clinical worsening event
Lasso di tempo: From enrollment through 5 years of follow-up

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/rescue 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause mortality
Lasso di tempo: From enrollment through 5 years of follow-up

Time from enrollment to death from any cause
From enrollment through 5 years of follow-up
Transplant-free survival
Lasso di tempo: From enrollment through 5 years of follow-up

Time to death or lung/heart-lung transplantation
From enrollment through 5 years of follow-up
PAH-related hospitalization
Lasso di tempo: From enrollment through 5 years of follow-up

Time to first PAH-related unplanned hospitalization and recurrent hospitalization burden
From enrollment through 5 years of follow-up
Change From Baseline in REVEAL 2.0 Risk Score
Lasso di tempo: Baseline to longitudinal follow-up through 5 years

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
Change From Baseline in ESC/ERS Four-Strata Risk Status
Lasso di tempo: Baseline to longitudinal follow-up through 5 years

PAH risk status will be assessed using the ESC/ERS 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.
Baseline to longitudinal follow-up through 5 years
Change From Baseline in WHO Functional Class
Lasso di tempo: Baseline to 3-6 months, 12 months, and annual follow-up through 5 years.

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.
Change From Baseline in 6-Minute Walk Distance
Lasso di tempo: Baseline to 3-6 months, 12 months, and annual follow-up through 5 years.

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.
Baseline to 3-6 months, 12 months, and annual follow-up through 5 years.
Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide
Lasso di tempo: Baseline to 3-6 months, 12 months, and annual follow-up through 5 years.

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.
Baseline to 3-6 months, 12 months, and annual follow-up through 5 years.
Change From Baseline in Right Atrial Pressure
Lasso di tempo: Baseline to repeat right-heart catheterization during follow-up, up to 5 years

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
Change From Baseline in Mean Pulmonary Artery Pressure
Lasso di tempo: Baseline to repeat right-heart catheterization during follow-up, up to 5 years

Mean pulmonary artery pressure will be measured by right-heart catheterization. Longitudinal change will be evaluated when repeat right-heart catheterization data are available.
Baseline to repeat right-heart catheterization during follow-up, up to 5 years
Change From Baseline in Pulmonary Arterial Wedge Pressure
Lasso di tempo: Baseline to repeat right-heart catheterization during follow-up, up to 5 years

Pulmonary arterial wedge pressure will be measured during right-heart catheterization.
Baseline to repeat right-heart catheterization during follow-up, up to 5 years
Change From Baseline in Cardiac Index
Lasso di tempo: Baseline to repeat right-heart catheterization during follow-up, up to 5 years

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.
Baseline to repeat right-heart catheterization during follow-up, up to 5 years
Change From Baseline in Pulmonary Vascular Resistance
Lasso di tempo: Baseline to repeat right-heart catheterization during follow-up, up to 5 years

Pulmonary vascular resistance will be calculated from invasive hemodynamic measurements obtained during right-heart catheterization.
Baseline to repeat right-heart catheterization during follow-up, up to 5 years
Change From Baseline in Respiratory Event Index
Lasso di tempo: Baseline to repeat sleep monitoring during follow-up, up to 5 years

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
Change From Baseline in Apnea-Hypopnea Index
Lasso di tempo: Baseline to repeat polysomnography during follow-up, up to 5 years

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
Change From Baseline in Oxygen Desaturation Index
Lasso di tempo: Baseline to repeat sleep monitoring during follow-up, up to 5 years

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.
Baseline to repeat sleep monitoring during follow-up, up to 5 years
Change From Baseline in Percentage of Recording Time With Oxygen Saturation Below 90% (T90)
Lasso di tempo: Baseline to repeat sleep monitoring during follow-up, up to 5 years

T90 will be defined as the percentage of valid overnight recording time during which peripheral oxygen saturation is below 90%.
Baseline to repeat sleep monitoring during follow-up, up to 5 years
Change From Baseline in Mean Overnight Oxygen Saturation
Lasso di tempo: Baseline to repeat sleep monitoring during follow-up, up to 5 years

Mean peripheral oxygen saturation will be calculated across the valid overnight recording period.
Baseline to repeat sleep monitoring during follow-up, up to 5 years
Change From Baseline in Minimum Overnight Oxygen Saturation
Lasso di tempo: Baseline to repeat sleep monitoring during follow-up, up to 5 years

Minimum peripheral oxygen saturation will be defined as the lowest valid oxygen saturation value recorded during the overnight monitoring period after signal-quality control.
Baseline to repeat sleep monitoring during follow-up, up to 5 years
Change From Baseline in Respiratory Event-Associated Hypoxic Burden
Lasso di tempo: Baseline to repeat sleep monitoring during follow-up, up to 5 years

Respiratory event-associated hypoxic burden will quantify the cumulative area under oxygen desaturation curves associated with scored respiratory events, normalized by recording duration.
Baseline to repeat sleep monitoring during follow-up, up to 5 years
Change From Baseline in Mean Event-Related Heart-Rate Surge
Lasso di tempo: Baseline to repeat sleep monitoring during follow-up, up to 5 years

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.
Baseline to repeat sleep monitoring during follow-up, up to 5 years
Change From Baseline in Tricuspid Annular Plane Systolic Excursion
Lasso di tempo: Baseline to annual follow-up through 5 years.

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.
Change From Baseline in Right Ventricular Fractional Area Change
Lasso di tempo: Baseline to annual follow-up through 5 years.

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.
Baseline to annual follow-up through 5 years.
Change From Baseline in TAPSE/sPAP Ratio
Lasso di tempo: Baseline to annual follow-up through 5 years.

The ratio of tricuspid annular plane systolic excursion to systolic pulmonary artery pressure (TAPSE/sPAP) 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.
Baseline to annual follow-up through 5 years.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Predictive Performance of AI-Enabled Multimodal Models for Major Clinical Worsening
Lasso di tempo: From baseline assessment through 5 years of follow-up.

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.
Treatment-Response Heterogeneity According to Baseline Sleep Phenotype
Lasso di tempo: From treatment initiation or escalation to the subsequent clinical reassessment, generally within 3-12 months, and through 5 years of follow-up.

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/ERS 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chinese Pulmonary Vascular Disease Research Group

Collaboratori

Chinese Academy of Medical Sciences, Fuwai Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

31 dicembre 2031

Completamento dello studio (Stimato)

31 dicembre 2032

Date di iscrizione allo studio

Primo inviato

15 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 settembre 2026

Primo Inserito (Effettivo)

1 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PAH-SDB Study

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified participant-level data and a data dictionary may be shared with qualified academic investigators for scientifically sound, non-commercial research after approval by the registry Steering Committee and relevant ethics/data-governance bodies, subject to a data-use agreement and applicable Chinese regulations. Data that could enable participant re-identification will not be shared.

Periodo di condivisione IPD

Beginning after publication of the principal registry analyses and after completion of required governance review; a practical default is 12-24 months after primary publication, for a defined period specified in the approved data-use agreement.

Criteri di accesso alla condivisione IPD

Written research proposal, methodological review, investigator qualifications, ethics approval where required, data-use agreement, secure analysis environment, and commitment not to attempt re-identification or unauthorized redistribution.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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