The Clinical Impact of Anemia of Chronic Disease on Chronic Obstructive Pulmonary Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- The primary outcome measure is peak oxygen uptake (VO2 peak, ml/kg/min) during maximal cardiopulmonary exercise testing and whether it differs between patients with ACD and COPD and patients with COPD without ACD.
研究概览
简要总结
Hypothesis:
The first part of the study is a survey on the prevalence of anemia of chronic disease (ACD) among COPD patients. The 2nd and 3rd part will test 2 null hypotheses (Ho): 1.serum inflammatory markers and plasma erythropoietin do not differ between COPD patients with and without ACD and 2. exercise capacity does not differ between COPD patients with and without ACD.
Rationale-Aim:
ACD is an immune driven disorder, developing in subjects suffering from chronic inflammatory diseases. COPD is a disorder very likely to be associated to ACD due to its systemic inflammatory dimension. Currently, data on the prevalence of ACD and on the level of inflammatory markers which are implicated in the pathogenesis of ACD in COPD subjects are limited and controversial. Furthermore, there is no data on the effect of ACD on exercise capacity of COPD subjects.
Based to the aforementioned, this study has three goals:
- to determine the prevalence and the epidemiologic characteristics of ACD in a population of clinical stable COPD patients
- to investigate whether the levels of serum inflammatory markers and of plasma erythropoietin differ between COPD patients with ACD and without ACD
- to determine potential differences regarding the aerobic exercise capacity between these two groups, using the cardiopulmonary exercise testing (CPET).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1st part of the study:
- •COPD clinically stable (patients with post-bronchodilation FEV1/FVC <0.7 and no acute exacerbations, hospital admissions or treatment changes in the last 3 months).
- •2nd and 3rd part:
- •As above.
排除标准
- •1st part of the study:
- •history of asthma,
- •history of respiratory infection in the last 3 months
- •2nd and 3rd part: As above and additionally:
- •history of malignancy or haematologic disorder
- •acute or chronic inflammatory disease
- •systematic or autoimmune disorder
- •thyroid disease
- •liver cirrhosis
- •heart failure (ejection fraction <55%)
- •history of gastrointestinal or other hemorrhage
- •renal failure (GFR<60 ml/min/1.73m2)
- •blood transfusion in the last 4 months
- •administration of cortisone in the last month
- •pregnancy
- •mental impairment
- •medical conditions which are contraindications to exercise testing, such as:
- •acute myocardial infarction (in the last 6 months)
- •unstable angina
- •left main coronary stenosis or its equivalent
- •symptomatic severe aortic stenosis or other moderate stenotic valvular disease
- •uncontrolled arrhythmias causing symptoms
- •acute pulmonary embolus or pulmonary infarction
- •thrombosis of lower extremities
- •suspected dissecting aneurysm
- •pulmonary oedema
- •room air desaturation at rest <85%
- •severe untreated arterial hypertension at rest (>200 mmHg systolic, >120 mmHg diastolic)
- •high degree atrioventricular block
- •hypertrophic cardiomyopathy and
- •orthopedic impairment that compromises exercise performance
结局指标
主要结局
The primary outcome measure is peak oxygen uptake (VO2 peak, ml/kg/min) during maximal cardiopulmonary exercise testing and whether it differs between patients with ACD and COPD and patients with COPD without ACD.
时间窗: Within 15 days from enrollment
次要结局
- Serum levels of inflammatory markers(Within 15 days from enrollment)
- Erythropoietin(Within 15 days from enrollment)
- MRC dyspnea scale(Within 15 days from enrollment)
- The rest cardiopulmonary exercise testing parameters(Within 15 days from enrollment)