Transforming Growth Factor Beta Signalling in the Development of Muscle Weakness in Pulmonary Arterial Hypertension
2018年9月24日 更新者:Imperial College London
Pulmonary arterial hypertension (PAH) is a disease that causes raised blood pressure in blood vessels that pick up oxygen from the lungs.
It has a life expectancy similar to some cancers.
There is treatment available but there is no cure.
We now know that PAH is associated with weakness in the muscles in the legs, which contributes to the symptoms patients' experience.
Researchers believe that certain proteins found in high levels in the blood of patients with other chronic diseases can affect muscle function and growth.
One of these proteins is called growth differentiating factor (GDF) 8, high levels of which are associated with muscle weakness in chronic obstructive pulmonary disease(COPD) and heart failure (HF).
Interestingly there are drugs available which block the actions of GDF-8 on muscle cells which has been shown in animals to result in increased muscle size.
A related protein called GDF-15 is found in elevated levels in patients PAH, and is linked to prognosis.
Our preliminary data suggests that GDF-15 can also directly influence muscle size in a number of situations.
We aim to investigate the role of GDF-15 and related molecules in the development of muscle weakness in patients with PAH.
We will do this by measuring certain markers of muscle weakness and taking blood and muscle samples in patients and controls.
We will then compare the levels of GDF-15 in these tissues in those with and without muscle wasting.
We hope this work will lead to a greater understanding of the role of GDF-15 in the development of muscle weakness in patients with PAH.
GDF-15 levels may be important in allowing us to define which patients have muscle weakness.
In the future we aim to perform a clinical trial of drugs which block the actions of GDF-15.
研究概览
研究类型
观察性的
注册 (实际的)
33
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
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London、英国、SW36NP
- Royal Brompton Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
14年 至 61年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Clinics at Royal Brompton and Hammersmith hospital
描述
Inclusion Criteria:
- Patients with pulmonary arterial hypertension with New York Heart Association stage II - III disease will be eligible for recruitment in the patient portion of the trial. Interested healthy age matched volunteers will also be recruited.
Exclusion Criteria:
- Patients and volunteers will be excluded if they have significant co-morbidities including other cardiorespiratory disease, metabolic abnormalities including diabetes or thyroid disorders. They will be excluded if they cannot safely exercise and perform a six minute walk test or if they are wheelchair bound.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:其他
队列和干预
团体/队列 |
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PH with wasting
This group of patients with idiopathic pulmonary arterial hypertension exhibit quadriceps wasting
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PH no wasting
This groups of patients with idiopathic pulmonary arterial hypertension exhibit no evidence of muscle wasting
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Controls
This group of volunteers does not have pulmonary arterial hypertension and would not be expected to have muscle wasting
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Plasma growth and differentiation factor 15 levels in participants with and without muscle wasting
大体时间:30 months
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Muscle wasting will be defined by quadriceps cross sectional area measured by ultrasound
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30 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of plasma Growth and differentiation factor 15 levels with muscle strength
大体时间:30 months
|
Muscle strength will be measured by quadriceps maximal volitional capacity percent predicted
|
30 months
|
|
Change in fibre type in muscle biopsy
大体时间:30 months
|
30 months
|
|
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GDF-15 levels in biopsy specimens
大体时间:30 months
|
30 months
|
|
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Correlation of plasma Growth and differentiation factor 15 levels with brain natriuretic protein levels
大体时间:30 months
|
30 months
|
|
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Correlation of plasma Growth and differentiation factor 15 levels with fat free mass index
大体时间:30 months
|
Fat free mass index will be measured by bioelectrical impedence
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30 months
|
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Correlation of plasma Growth and differentiation factor 15 levels with quality of life
大体时间:30 months
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Quality of life will be measured by St. George's respiratory questionnaire
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30 months
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Correlation of plasma Growth and differentiation factor 15 levels with exercise tolerance
大体时间:30 months
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Exercise tolerance will be measured by six minute walk test
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30 months
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Correlation of plasma Growth and differentiation factor levels 15 with physical activity levels
大体时间:30 months
|
Physical activity will be measured by Sensewear armband
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30 months
|
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Correlation of plasma Growth and differentiation factor levels 15 with echocardiographic measures of severity of pulmonary hypertension
大体时间:30 months
|
30 months
|
|
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Correlation of GDF-15 levels in biopsy specimens with muscle wasting and weakness
大体时间:30 months
|
Wasting will be measured by quadriceps cross sectional area and weakness will be defined by quadriceps maximal volitional capacity
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30 months
|
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Determine the contribution of atrophy and autophagy to muscle wasting in PAH
大体时间:30 months
|
Muscle biopsy specimens will be evaluated using microscopy and real time polymerase chain reaction
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30 months
|
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Determine the contribution of SMAD and non-SMAD signalling pathways to the development of muscle weakness and wasting in PAH
大体时间:30 months
|
Phosphorylation of SMAD and non-SMAD signalling will be determined by western blot
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30 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Stephen J Wort, MBBS、Imperial College / Royal Brompton Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年10月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2013年4月19日
首先提交符合 QC 标准的
2013年5月2日
首次发布 (估计)
2013年5月7日
研究记录更新
最后更新发布 (实际的)
2018年9月26日
上次提交的符合 QC 标准的更新
2018年9月24日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.