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

NCT03357913 | Completed

• 1 other identifier: MUCO TRANSPLAN
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Failure; Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

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.

Other: Lung transplantation

Interventions

Lung transplantation 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

Co morbidities after lung transplantation in cystic fibrosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Lung Transplantation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 30, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: October 30, 2017
• Last Updated: November 30, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)