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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05595200
Acronym
POSAPH
Enrollment
480
Registered
2022-10-26
Start date
2020-05-01
Completion date
2025-12-31
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidemiology, Mortality, Obstructive Sleep Apnea, Outcomes, Predictor, Prognosis, Pulmonary Hypertension, Sleep Apnea

Keywords

Sleep Apnea, Pulmonary Hypertension, Obstructive Sleep Apnea, Hypoxemia, Prognosis, Prevalence, Predictor, Phenotype, Outcome

Brief 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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTLevel III portable sleep study

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

Sponsors

Chinese Pulmonary Vascular Disease Research Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical worsening1 yearThe 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

MeasureTime frameDescription
Individual clinical worsening outcomes1 year, 3 years and 5 yearsNumber of patients with reduction in exercise capacity, reduction in WHO functional classes, non-elective hospitalization for pulmonary hypertension and all-cause mortality.
Clinical worsening3 year, 5 yearsThe 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.
All-cause mortality1 year, 3 year, 5 yearsAll-cause mortality

Countries

China

Contacts

Primary ContactZhihong Liu, M.D., Ph.D
zhihongliufuwai@163.com+861088396590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026