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Non-respiratory Comorbidities Observed in Pulmonary French Transplant Patients With Cystic Fibrosis

NCT ID: NCT03357913

Last Updated: 2017-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2017-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Failure Cystic Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Co morbidities after lung transplantation in cystic fibrosis

The population studied is the cohort of cystic fibrosis patients who received a bipulmonary transplant between 2004 and 2014 in one of the two transplantation centers in the Rhône-Alpes region.

Lung transplantation

Intervention Type OTHER

To estimate the incidence of non-respiratory co-morbidities after lung transplantation between 2004 and 2014 in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region

Interventions

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Lung transplantation

To estimate the incidence of non-respiratory co-morbidities after lung transplantation between 2004 and 2014 in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Pierre-Bénite, , France

Site Status

Countries

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France

Other Identifiers

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MUCO TRANSPLAN

Identifier Type: -

Identifier Source: org_study_id