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

Obstructive Sleep Apnea Clinical Trial

— POSAPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05595200
• Other study ID #: SAPH
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Chinese Pulmonary Vascular Disease Research Group
• Contact: Zhihong Liu, M.D., Ph.D
• Phone: +861088396590
• Email: zhihongliufuwai[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Country	Name	City	State
China	Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Pulmonary Vascular Disease Research Group

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical worsening	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.	1 year
Secondary	Individual clinical worsening outcomes	Number of patients with reduction in exercise capacity, reduction in WHO functional classes, non-elective hospitalization for pulmonary hypertension and all-cause mortality.	1 year, 3 years and 5 years
Secondary	Clinical worsening	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.	3 year, 5 years
Secondary	All-cause mortality	All-cause mortality	1 year, 3 year, 5 years