Clinical trial NCT03357913: Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis
Official title: Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis - Exploratory Study From the French Cohort on 2004-2014.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Failure
Cystic Fibrosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population studied is the cohort of patients with cystic fibrosis who received a bipulmonary transplant between 2004 and 2014 in one of the two transplant centers in the Rhône-Alpes region.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of co-morbidities after lung transplantation
timeFrame: 1 year
measure: Incidence of co-morbidities after lung transplantation
timeFrame: 2 years
measure: Incidence of co-morbidities after lung transplantation
timeFrame: 5 years
measure: Incidence of co-morbidities after lung transplantation
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Study officials:
References: