Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
- Conditions
- Sleep ApneaOutcomesObstructive Sleep ApneaPulmonary HypertensionEpidemiologyPredictorPrognosisMortality
- Interventions
- Diagnostic Test: Level III portable sleep study
- Registration Number
- NCT05595200
- Lead Sponsor
- Chinese Pulmonary Vascular Disease Research Group
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
- Aged ≥18 years old
- Diagnosed with pulmonary hypertension by right heart catheterization
- Pregnancy
- Central sleep apnea
- Previous treatment for sleep-disordered breathing
- Unavailable or incomplete sleep data
- Requiring nocturnal oxygen supplementation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Group Level III portable sleep study All subjects diagnosed with pulmonary hypertension by right heart catheterization agreeing to participate and meeting inclusion criteria but not meeting exclusion criteria
- Primary Outcome Measures
Name Time Method Clinical worsening 1 year 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 Outcome Measures
Name Time Method Individual clinical worsening outcomes 1 year, 3 years and 5 years Number of patients with reduction in exercise capacity, reduction in WHO functional classes, non-elective hospitalization for pulmonary hypertension and all-cause mortality.
Clinical worsening 3 year, 5 years 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.
All-cause mortality 1 year, 3 year, 5 years All-cause mortality
Trial Locations
- Locations (1)
Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC
🇨🇳Beijing, China