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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Aged ≥18 years old.

- Diagnosed with pulmonary hypertension by right heart catheterization.

Exclusion Criteria:

- Pregnancy.

- Central sleep apnea.

- Previous treatment for sleep-disordered breathing.

- Unavailable or incomplete sleep data.

- Requiring nocturnal oxygen supplementation

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05595200
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Chinese Pulmonary Vascular Disease Research Group
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Zhihong Liu
Principal Investigator Affiliation	Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sleep Apnea, Obstructive Sleep Apnea, Pulmonary Hypertension, Epidemiology, Predictor, Prognosis, Outcomes, Mortality

Additional Details

Obstructive sleep apnea (OSA) is a highly prevalent sleep-breathing disorder that affects over 1 billion adults worldwide, resulting in a substantial economic and medical burden. Multiple cardiovascular comorbidities and mortality are associated with OSA due to intermittent hypoxemia, intrathoracic pressure swings, sympathetic activation, endothelial dysfunction, and systemic inflammation. Large epidemiological studies have shown that OSA is more prevalent in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension than in the general population. Thus, elucidating the effects of OSA on adverse outcomes in patients with pulmonary hypertension is crucial in risk assessments and therapeutic recommendations for affected individuals. There is, however, insufficient evidence to determine whether OSA and associated physiological sequelae/phenotypes have a prognostic impact on these patients. 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 (15% compared with the previous six-minute walk distance), worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension (need for an intravenous diuretic or inotropic drugs, new targeted therapies, lung transplantation, or septostomy), or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.

Arms & Interventions

Arms

: Study Group

All subjects diagnosed with pulmonary hypertension by right heart catheterization agreeing to participate and meeting inclusion criteria but not meeting exclusion criteria

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.