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RECRUITING
NCT05595200

Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension

Sponsor: Chinese Pulmonary Vascular Disease Research Group

View on ClinicalTrials.gov

Summary

The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Adult patients diagnosed with pulmonary hypertension by right heart catheterization are eligible. Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge. The cardiorespiratory tracings during sleep will be analyzed and audited by a certified sleep physician. The patients will be divided into two groups based on the apnea-hypopnea index (AHI): OSA (AHI ≥ 5) and non-OSA (AHI\<5) groups. Hypoxemic parameters such as time percentage spent with oxygen saturation below 90% and nadir oxygen saturation were all collected. Baseline clinical characteristics, such as the Epworth sleepiness scales, were also obtained. The primary endpoint of this study was clinical worsening (CW), defined as the composite event of a reduction in exercise capacity, worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension, or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

480

Start Date

2020-05-01

Completion Date

2028-12-31

Last Updated

2026-10-26

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Level III portable sleep study

Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge

Locations (1)

Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC

Beijing, China