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临床试验/NCT03357913
NCT03357913已完成不适用

Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis - Exploratory Study From the French Cohort on 2004-2014.

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Incidence of co-morbidities after lung transplantation

研究概览

简要总结

Pulmonary transplantation is the reference treatment for chronic terminal respiratory failure in patients with cystic fibrosis. These are mainly bi-pulmonary transplants (cardiopulmonary transplants are exceptional). The annual number of pulmonary transplants in France for cystic fibrosis is about 90. In 2013, the transplant involves a total of more than 600 patients with cystic fibrosis. The average age at the time of the transplant is 28.5 years (2013 data, French cystic fibrosis register), compared to 58 years for patients transplanted to all pathologies. Cystic fibrosis accounts for 25% of adult bi-pulmonary grafts. Pediatric transplants are currently very rare.

The median survival after pulmonary transplantation in cystic fibrosis is currently 8.5 years (and 10 years when considering patients surviving 3 months, ie excluding early mortality). Cystic fibrosis is the pathology associated with better survival after pulmonary transplantation given the young age of patients (28.5 years on average).

The non-respiratory comorbidities associated with transplantation, all underlying pathologies combined, and referenced in the Registry of the International Society for Heart and Lung Transplantation (ISHLT) are: hypertension, diabetes, renal insufficiency, Dyslipidemia, cancers. Their frequency increases with the survival time of transplanted patients. Cystic fibrosis is associated with non-respiratory comorbidities, the frequency of which increases with age - diabetes, osteoporosis, renal insufficiency, hepatopathy, neoplastic pathologies - and may become worse after transplantation.

The main objective is to estimate the incidence of non-respiratory co-morbidities after lung transplantation in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with clinical diagnosis of cystic fibrosis
  • Patients with Pulmonary transplant between 01/01/2004 and 31/12/2014
  • Patients followed-up in one of the two pulmonary transplantation centers in the Rhône-Alpes region (Lyon, Grenoble)

排除标准

  • Patients followed in Rhône Alpes but transplanted elsewhere in France will not be included.
  • Patient refusing to participate in the study

结局指标

主要结局

Incidence of co-morbidities after lung transplantation

时间窗: 10 years

The incidence rate will be calculated at 10 years follow-up after lung transplantation. The comorbidities studied will be: * diabetes * kidney failure * high blood pressure * hepatopathies * undernutrition * osteoporosis * neoplasms, and in particular colon cancer * gynecological complications (viral and neoplastic)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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