A Prospective Observational Study Investigating Whether Nocturnal Hypoxaemia and Exercise Induced Desaturation Predict Functional Deterioration in Patients With Fibrotic Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in 6-minute walk distance
研究概览
简要总结
This is an observational clinical research study investigating patients with fibrotic interstitial lung disease (fILD), also known as pulmonary fibrosis.
It is not known why some patients with fILD clinically deteriorate. This study will investigate whether measuring oxygen levels during sleep or exercise can help identify patients who are at increased risk of clinical deterioration.
详细描述
This work will build upon the FIBRINOX study, previous clinical research conducted by the Guy's and St Thomas' ILD research team. The FIBRINOX study showed that patients with fILD and normal oxygen saturations at rest, but who desaturate whilst asleep or during exercise, have a significantly increased mortality and greater reduction in quality of life compared to patients who do not desaturate at night or during exercise.
The reasons for these differences in mortality and health related quality of life are not known. Data suggests that worsening fILD and the development of pulmonary hypertension, a condition characterised by increased pressure in the pulmonary arteries that is associated with poorer outcomes, may be playing a role.
This clinical research study will recruit approximately 160 patients with a tertiary ILD centre diagnosis of fibrotic interstitial lung disease (fILD). Data from routinely performed investigations as part of tertiary ILD assessment will be systematically recorded.
Investigations will include lung function tests, echocardiography, blood tests, a 6-minute walk test and overnight oximetry. Participants will also complete several quality-of-life questionnaires. These investigations will be performed at baseline, and again at 12 months, with all tests also repeated at 6 months except for an echocardiogram. After the initial 1 year study period, a 3 year post-recruitment mortality and right heart catheter check will be performed using the participants' medical records. Data will be collected from CT scans and right heart catheters if performed during the study period as part of the participants usual clinical care.
This study is designed to establish whether patients with fILD who desaturate during sleep or exercise are more likely to experience functional decline, as well as confirm previous findings of increased mortality and worsening quality of life as demonstrated in the FIBRINOX study. The data generated by this observational study will help generate future hypotheses, research questions and clinical study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 year and over
- •Tertiary MDT diagnosis of FILD with >10% fibrosis on CT chest as determined by the investigator. Underlying diagnoses to include but not limited to: idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), connective tissue disease-related interstitial lung disease (CTD-ILD), fibrotic organising pneumonia (FOP) and pulmonary sarcoidosis.
- •Able to provide informed written consent
排除标准
- •The use of or any indication for long-term oxygen therapy (LTOT)
- •Known moderate or severe obstructive sleep apnoea with an apnoea/hypopnoea index (AHI) or oxygen desaturation index (ODI) over 15 events per hour
- •Radiological predominance of emphysema compared with fibrosis on CT chest
- •Inability to complete all health status questionnaires as set out in this protocol, with appropriate support
- •A confirmed diagnosis of pulmonary hypertension
- •Significant cardiovascular comorbidity including severe, uncontrolled hypertension, uncontrolled arrhythmia, recent acute coronary syndrome within 30 days prior to study enrolment, that could mean exercise testing poses a risk to patient health, in the opinion of the investigator
- •Musculoskeletal comorbidity that will preclude the participant's ability to reliably complete the complete 6-minute walk test (6MWT)
- •Participation in another research project which may confound this study's research findings
结局指标
主要结局
Change in 6-minute walk distance
时间窗: 52 weeks
As measured by 6-minute walk test
次要结局
- Pulmonary hypertension(52 and 156 weeks)
- Decline in TLCO(52 weeks)
- Change in arterialised capillary blood gas pCO2(52 weeks)
- Change in arterialised capillary blood gas HCO3(52 weeks)
- Change in arterialised capillary blood gas pH(52 weeks)
- Clinical deterioration(52 weeks)
- Decline in FVC(52 weeks)
- Mortality(52 and 156 weeks)
- Change in arterialised capillary blood gas pO2(52 weeks)
- Change in arterialised capillary blood gas oxygen saturations(52 weeks)
- Change in cardiac chamber size/area(52 weeks)
- Change in TAPSE/sPAP ratio(52 weeks)
- Rate of acute exacerbation of fILD(52 weeks)
- Change in troponin level(52 weeks)
- Change in cardiac chamber area(52 weeks)
- Change in MPA:AA diameter ratio(52 weeks)
- Time to first acute exacerbation of fILD(52 weeks)
- Change in King's Brief Interstitial Lung Disease (KBILD) questionnaire score(52 weeks)
- Change in RV/LV basal diameter area ratio(52 weeks)
- Change in NT-proBNP/BNP level(52 weeks)
- Change in peak TRV(52 weeks)
- Change in European Quality of Life 5-Dimensions 5-Levels (EQ-5D-5L) questionnaire score(52 weeks)
- Change in Living with Pulmonary Fibrosis (L-IPF) questionnaire score(52 weeks)