Prospective Observational Study to Assess the Influence of Intermittent Hypoxaemia on Lung Function Decline, Morbidity, and Mortality in COPD Patients (PROSA Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Difference in FEV1(% of LLN) between baseline and end-of-follow-up
研究概览
简要总结
This study aims to analyze if patients with chronic obstructive lung disease who experience a decline of blood oxygen saturation during physical exercise have a disease course different from that of COPD patients who do not experience a decline in blood oxygen saturation during exercise. Patients will be followed for a total of 3 years.
详细描述
The major aim of the study is to test whether intermittent hypoxaemia is a major driver of the progression of chronic obstructive lung disease (COPD). The second aim is to analyse whether dysregulation of the L-arginine / dimethylarginine pathway is a mechanistic link between intermittent hypoxemia and lung function decline, and whether plasma biomarkers are suitable to identify COPD patients at high risk of rapid lung function decline and mortality.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes with a diagnosis of chronic obstructive lung disease (COPD) stages 2-3, groups B and E according to GOLD 38 as assessed by their primary family doctor or pneumology specialist who are treated with long-acting bronchodilators on a stable dose for at least four months prior to inclusion into the study;
- •Age at inclusion 18 - 80 years;
- •Physical ability and willingness to perform 6-minute walk testing and bicycle ergometry testing;
- •Signed written informed consent form
排除标准
- •Participation in another clinical study within the last 3 months before inclusion into the present study;
- •Any somatic or psychic disease that may hamper participation in the study or compliance with the study protocol (at the investigator's discretion);
- •Any somatic disease that puts the patient at increased risk when performing the exercise tests or impairs the patient's ability to properly perform the exercise tests, like advanced coronary artery disease, advanced chronic heart failure, uncontrolled hypertension, orthopaedic, or neurological diseases (non-exclusive list of examples);
- •Any disease or health condition that reduces the patient's life expectancy to less than the expected time frame of this study, other than chronic obstructive lung disease (at the investigator's discretion);
- •Pregnancy or nursing.
结局指标
主要结局
Difference in FEV1(% of LLN) between baseline and end-of-follow-up
时间窗: 3 years
The difference in measured FEV1 assessed by spirometry and expressed as percent of the lower limit of the normal distribution based upon the Global Lung Function 2022 Equations, by comparing results of the baseline measurement with those of the last investigation during up to three years of follow-up
次要结局
- Difference in all-cause mortality during follow-up between groups(3 years)
- Difference in frequency of hospital admissions for causes other than exacerbation of COPD during follow-up between groups(3 years)
- Sensitivity of plasma biomarkers (spec. ADMA and SDMA) to predict the prevalence of exertional desaturation in COPD patients(3 years)
- Difference in COPD-related mortality during follow-up between groups(3 years)
- Sensitivity and specificity of plasma biomarkers (spec. ADMA and SDMA) measured at baseline to prospectively predict the slope of lung function decline in COPD patients(3 years)
- Difference in frequency of hospital admissions for exacerbation of COPD during follow-up between groups(3 years)
- Sensitivity and specificity of plasma biomarkers at baseline to prospectively predict the mortality rate in COPD patients(3 years)
- Difference in incidence and extent of exercise hypoxemia between carriers and non-carriers of single nucleotide polymorphisms (SNPs) in genes of the L-arginine - dimethylarginine pathway(3 years)
- Difference in positive and negative predictive value of bicycle ergometry, 6-minute walk test, and 15-sec breath-hold test to discriminate between COPD patients with exertional desaturation versus those without exertional desaturation(3 years)
研究者
Prof. Rainer H. Böger
Prof. Dr. med. Dr. h.c.
Universitätsklinikum Hamburg-Eppendorf