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临床试验/NCT01847716
NCT01847716终止不适用

Transforming Growth Factor Beta Signalling in the Development of Muscle Weakness in Pulmonary Arterial Hypertension

Imperial College London1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
33
试验地点
1
主要终点
Plasma growth and differentiation factor 15 levels in participants with and without muscle wasting

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Plasma growth and differentiation factor 15 levels in participants with and without muscle wasting

时间窗: 30 months

Muscle wasting will be defined by quadriceps cross sectional area measured by ultrasound

次要结局

  • Correlation of plasma Growth and differentiation factor 15 levels with muscle strength(30 months)
  • Change in fibre type in muscle biopsy(30 months)
  • GDF-15 levels in biopsy specimens(30 months)
  • Correlation of plasma Growth and differentiation factor 15 levels with brain natriuretic protein levels(30 months)
  • Correlation of plasma Growth and differentiation factor 15 levels with fat free mass index(30 months)
  • Correlation of plasma Growth and differentiation factor 15 levels with quality of life(30 months)
  • Correlation of plasma Growth and differentiation factor 15 levels with exercise tolerance(30 months)
  • Correlation of plasma Growth and differentiation factor levels 15 with physical activity levels(30 months)
  • Correlation of plasma Growth and differentiation factor levels 15 with echocardiographic measures of severity of pulmonary hypertension(30 months)
  • Correlation of GDF-15 levels in biopsy specimens with muscle wasting and weakness(30 months)
  • Determine the contribution of atrophy and autophagy to muscle wasting in PAH(30 months)
  • Determine the contribution of SMAD and non-SMAD signalling pathways to the development of muscle weakness and wasting in PAH(30 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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