๐ฌIn plain words
What the trial is, and whether it could suit you
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, biomar
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Age โฅ18 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 โค15 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.
๐
What it tests
- Standardized Overnight Sleep and Cardiorespiratory Monitoring
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.