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

Completed

• Conditions: Cystic Fibrosis; Pulmonary Failure
• Interventions: Other: Lung transplantation

• Registration Number: NCT03357913
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2017-06-01
• Study Completion: 2017-10-30
• Status Verified: 2017-11
• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-29
• Last Update Submitted: 2017-11-29
• Study First Posted: 2017-11-30
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Co morbidities after lung transplantation in cystic fibrosis	Lung transplantation	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.

Primary Outcome Measures

Name	Time	Method
Incidence of co-morbidities after lung transplantation	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)

Trial Locations

Locations (1)

Service de médecine interne Centre Hospitalier Lyon Sud, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France