Clinical trial NCT04484948: Utility of Breath-holding Test in Systemic Sclerosis
Official title: Utility of Breath-holding Test for Assessment of Pulmonary Disease Severity in Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: Breath-holding test
Six minute walk test
Systemic sclerosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to evaluate the utility of breath-holding test as a marker of pulmonary disease severity in patients with systemic sclerosis.

Detailed description: Systemic sclerosis (SSc) is a chronic autoimmune disease of unknown etiology with high morbidity and mortality. SSc manifests by fibrosis of skin and internal organs. Although the underlying mechanisms are still subject to investigation, endothelial dysfunction and abnormal immune response are thought to contribute to vascular dysfunction and fibrosis in SSc.

Pulmonary involvement, such as pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) is a major cause of death in SSc. Although the 6MWT is generally used for evaluating PAH and ILD, the utility in SSc is undetermined. Several investigators have found weak or moderate correlations of 6MWT in pulmonary involvement in SSc. The 6MWT is influenced by the status of all organ systems involved in exercise (pulmonary, cardiac, peripheral vascular, neuromuscular unit and muscle metabolism) as well as by specifics of test conditions. There is a pressing need for new, practical method which corroborates the current 6MWT for the evaluation of pulmonary disease severity in SSc.

Breath-holding test (BHT) is one of the most useful methods for assessing the sensitivity of peripheral chemoreflex. Recent studies have demonstrated that BHT was correlated to pulmonary function test. BHT can be safely conducted and doctors handle a medical emergency during test easily as well. Therefore, this study evaluates the utility of BHT as surrogate marker of pulmonary involvement in patients with SSc.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of systemic sclerosis according to 2013 ACR/EULAR criteria
* Must understand and voluntarily sign an informed consent form including writing consent for data protection

Exclusion Criteria:

* The resting oxygen saturation by pulse oximetry \< 90% in room air
* Unstable angina or myocardial infarction during the previous month
* Patients considered unable to the breath-holding test or 6 minute walk test

Primary outcomes:
measure: Correlation of breath-holding test with Borg Dyspnea Index
timeFrame: Day 1 at inclusion
Secondary outcomes:
measure: Correlation of breath-holding time with 6 minute walk test (6MWT) distance
timeFrame: Day 1 at inclusion
measure: Correlation of breath-holding time with oxygen saturation during 6MWT
timeFrame: Day 1 at inclusion
measure: Correlation of breath-holding time with pulmonary function indices
timeFrame: Day 1 at inclusion
measure: Correlation of breath-holding time with data on the echocardiography
timeFrame: Day 1 at inclusion
measure: Correlation of breath-holding time with scleroderma health assessment questionnaire (SHAQ)
timeFrame: Day 1 at inclusion
Other outcomes:
measure: Changes of oxygen saturation during breath-holding test
timeFrame: Day 1 at inclusion
measure: Changes of oxygen saturation during of 6MWT
timeFrame: Day 1 at inclusion
measure: Responsiveness of breath-holding test
timeFrame: Month 6 at inclusion
measure: Reliability of breath-holding test
timeFrame: Day 1, and Day 7~Day14 at inclusion
measure: Development of the machine learning model to predict pulmonary parameters
timeFrame: Year 2 at inclusion
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine
name: Eun Bong Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University College of Medicine
name: Jina Yeo, MD
role: STUDY_DIRECTOR
References:
citation: Hachulla E, Launay D. Diagnosis and classification of systemic sclerosis. Clin Rev Allergy Immunol. 2011 Apr;40(2):78-83. doi: 10.1007/s12016-010-8198-y.
citation: Morelli S, Ferrante L, Sgreccia A, Eleuteri ML, Perrone C, De Marzio P, Balsano F. Pulmonary hypertension is associated with impaired exercise performance in patients with systemic sclerosis. Scand J Rheumatol. 2000;29(4):236-42. doi: 10.1080/030097400750041389.
citation: Vandecasteele E, De Pauw M, De Keyser F, Decuman S, Deschepper E, Piette Y, Brusselle G, Smith V. Six-minute walk test in systemic sclerosis: A systematic review and meta-analysis. Int J Cardiol. 2016 Jun 1;212:265-73. doi: 10.1016/j.ijcard.2016.03.084. Epub 2016 Mar 25.
citation: Impens AJ, Wangkaew S, Seibold JR. The 6-minute walk test in scleroderma--how measuring everything measures nothing. Rheumatology (Oxford). 2008 Oct;47 Suppl 5:v68-9. doi: 10.1093/rheumatology/ken273.
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
citation: Yeo J, Kim JY, Kim MH, Park JW, Park JK, Lee EB. Utility of the breath-holding test in patients with systemic sclerosis. Rheumatology (Oxford). 2022 Oct 6;61(10):4113-4118. doi: 10.1093/rheumatology/keac020.