Clinical trial NCT05595200: Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Official title: Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea
Obstructive Sleep Apnea
Pulmonary Hypertension
Epidemiology
Predictor
Prognosis
Outcomes
Mortality
Keywords: Sleep Apnea
Pulmonary Hypertension
Obstructive Sleep Apnea
Hypoxemia
Prognosis
Prevalence
Predictor
Phenotype
Outcome
Lead sponsor: Chinese Pulmonary Vascular Disease Research Group
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients admitted to Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College diagnosed with pulmonary hypertension that meet inclusion and exclusion criteria.

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.

Eligibility 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

Primary outcomes:
measure: Clinical worsening
timeFrame: 1 year
Secondary outcomes:
measure: Individual clinical worsening outcomes
timeFrame: 1 year, 3 years and 5 years
measure: Clinical worsening
timeFrame: 3 year, 5 years
measure: All-cause mortality
timeFrame: 1 year, 3 year, 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Zhihong Liu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duan A, Huang Z, Hu M, Zhao Z, Zhao Q, Jin Q, Yan L, Zhang Y, Li X, An C, Luo Q, Liu Z. The comorbidity burden and disease phenotype in pre-capillary pulmonary hypertension: The contributing role of obstructive sleep apnea. Sleep Med. 2023 Jan;101:146-153. doi: 10.1016/j.sleep.2022.10.029. Epub 2022 Nov 2.
citation: Huang Z, Duan A, Hu M, Zhao Z, Zhao Q, Yan L, Zhang Y, Li X, Jin Q, An C, Luo Q, Liu Z. Implication of prolonged nocturnal hypoxemia and obstructive sleep apnea for pulmonary hemodynamics in patients being evaluated for pulmonary hypertension: a retrospective study. J Clin Sleep Med. 2023 Feb 1;19(2):213-223. doi: 10.5664/jcsm.10286.
citation: Hu M, Duan A, Huang Z, Zhao Z, Zhao Q, Yan L, Zhang Y, Li X, Jin Q, An C, Luo Q, Liu Z. Development and Validation of a Nomogram for Predicting Obstructive Sleep Apnea in Patients with Pulmonary Arterial Hypertension. Nat Sci Sleep. 2022 Aug 9;14:1375-1386. doi: 10.2147/NSS.S372447. eCollection 2022.
citation: Huang Z, Duan A, Zhao Z, Zhao Q, Zhang Y, Li X, Zhang S, Gao L, An C, Luo Q, Liu Z. Sleep-disordered breathing patterns and prognosis in pulmonary arterial hypertension: A cluster analysis of nocturnal cardiorespiratory signals. Sleep Med. 2024 Jan;113:61-69. doi: 10.1016/j.sleep.2023.11.016. Epub 2023 Nov 13.