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

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.

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Key information

Conditions

Pulmonary Failure Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Pierre-Bénite, 69495, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

Incidence of co-morbidities after lung transplantation

Time frame: 1 year
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)
Incidence of co-morbidities after lung transplantation

Time frame: 2 years
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)
Incidence of co-morbidities after lung transplantation

Time frame: 5 years
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)
Incidence of co-morbidities after lung transplantation

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: MUCO TRANSPLAN

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Nov 30, 2017
Registry last updated: Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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