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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03357913
Other study ID # MUCO TRANSPLAN
Secondary ID
Status Completed
Phase N/A
First received November 20, 2017
Last updated November 29, 2017
Start date June 1, 2017
Est. completion date October 30, 2017

Study information

Verified date November 2017
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 30, 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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

Locations

Country Name City State
France Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon Pierre-Bénite

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of co-morbidities after lung transplantation The incidence rate will be calculated at 1 year 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)
1 year
Primary Incidence of co-morbidities after lung transplantation The incidence rate will be calculated at 2 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)
2 years
Primary Incidence of co-morbidities after lung transplantation The incidence rate will be calculated at 5 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)
5 years
Primary Incidence of co-morbidities after lung transplantation 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)
10 years
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