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

NCT05595200 | Unknown DMC

• 1 other identifier: SAPH
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Individual clinical worsening outcomes

  1 year, 3 years and 5 years

• Clinical worsening

  3 year, 5 years

• All-cause mortality

  1 year, 3 year, 5 years

Study Arms (1)

Study Group

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

Diagnostic Test: Level III portable sleep study

Interventions

Level III portable sleep study DIAGNOSTIC_TEST

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

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged ≥18 years old
• Diagnosed with pulmonary hypertension by right heart catheterization

You may not qualify if:

• Pregnancy
• Central sleep apnea
• Previous treatment for sleep-disordered breathing
• Unavailable or incomplete sleep data
• Requiring nocturnal oxygen supplementation

Sponsors & Collaborators

• Chinese Pulmonary Vascular Disease Research Group: lead

Study Sites (1)

Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC

Beijing, 100037, China

RECRUITING

Related 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.

  PMID: 36395719 BACKGROUND

• 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.

  PMID: 36081323 BACKGROUND

• 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.

  PMID: 35971464 BACKGROUND

• 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.

  PMID: 37984019 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension, Pulmonary; Hypoxia

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhihong Liu

  Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihong Liu, M.D., Ph.D

CONTACT

+861088396590; zhihongliufuwai@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 26, 2022
• Study Start: May 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 17, 2024

Record last verified: 2023-12

Locations

CN (1)