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

30. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

1500

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
      • Beijing, China, 100037
        • Rekrutierung
        • Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Diagnosetest: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Prevalence and phenotypic distribution of sleep-disordered breathing and nocturnal hypoxemia
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
All-cause mortality
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Predictive Performance of AI-Enabled Multimodal Models for Major Clinical Worsening
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chinese Pulmonary Vascular Disease Research Group

Mitarbeiter

Chinese Academy of Medical Sciences, Fuwai Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2031

Studienabschluss (Geschätzt)

31. Dezember 2032

Studienanmeldedaten

Zuerst eingereicht

15. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

30. September 2026

Zuerst gepostet (Tatsächlich)

1. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PAH-SDB Study

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

IPD-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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