Czech AATD Registry
ConditionAlpha-1-antitrypsin Deficiency
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThomayer University Hospital
About this trial
Alpha-1-antitrypsin deficiency is the most common congenital disease of the respiratory system, leading to early pulmonary emphysema or bronchiectasis. Pulmonary involvement significantly accelerates active cigarette smoking. Patients with alpha-1-antitrypsin deficiency may also have liver cirrhosis, vasculitis, skin or intestinal disorders.
The AATD Registry is a non-interventional multicenter retrospective prospective longitudinal follow-up of patients with alpha-1-antitrypsin deficiency.
The aim of the AATD National Registry is to collect and analyze clinical data in patients with alpha-1 antitrypsin deficiency.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with alpha-1-antitrypsin deficiency
Disqualifiers
Patient disagreement with inclusion in the study
Trial population
Patients with alpha-1-antitrypsin deficiency
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Changes of lung function parameters over time
assessement of the rate of decline of FEV1 (ml, %predicted), measured annually
Time frame
within one year after completion2
Changes of exercise tolerance tolerance over time
assessment of changes of peak oxygen consumption (peakVO2, ml/kg/min) measured every two years
Time frame
within one year after completion3
Changes of respiratory function over time
assessement of the rate of decline of TLco (mol/min/kPa, %predicted), measured annually
Time frame
within one year after completion4
Changes of quality of life over time
assessement of the rate of decline of COPD assessment test (CAT, points), measured annually
Time frame
within one year after completionSecondary outcomes
1
Behavior of individuals with no or minimal lung involvement
Assessement of prognosis of deficient non-smokers by monitoring primary outcome parameters 1-3
Time frame
within one year after completion2
Progression of other organ disorders, namely liver
Laboratory detection of changes in liver tests (ALT, AST, ALP, GGT, ukat/l)
Time frame
within one year after completionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Thomayer University Hospital
Lead sponsor
Masaryk University
Collaborator
Source ClinicalTrials.gov