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

Cystic Fibrosis Clinical Trial

— MUCO TRANSPLAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357913
• Other study ID #: MUCO TRANSPLAN
• 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
• 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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Pulmonary Failure

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