Disorder Related to Lung Transplantation
Conditions
Keywords
lung transplantation, electrocardiography, macrolides, QTc interval, arrhythmia
Brief summary
Experimental intervention: electrocardiography. Control intervention: none Duration of intervention per patient/subject: 5 min, observation 6 months Key inclusion criteria: * outpatients after lung transplantation (single, double or combined) * outpatients on the wait list for lung transplantation Key exclusion criteria: • no informed consent
Detailed description
Primary endpoint: • prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation Key secondary endpoint(s): * prevalence of any QTc-interval prolongation (\>440 msec ) after lung transplantation * prevalence of PQ prolongation (200 msec sec or above) after lung transplantation * prevalence of QRS prolongation (120 msec or above) after lung transplantation * prevalence of QTc-prolonging drugs in drug regimen before and after lung transplantation * influence of long-term neo-macrolide (e.g. azithromycin) on QTc interval after lung transplantation * intra-individual difference of QTc interval before and after lung transplantation * incidence of any QTc-interval prolongation(\>440 msec ) after lung transplantation * incidence of any QTc-interval prolongation (\>440 msec or increase by 50msec or above) after initiation of new QTc prolonging drugs (especially neo-macrolides) * reversal of QTc-interval prolongation (440 msec or lower or decrease by 50msec or above) after stopping any QTc prolonging drug * Assessment of safety: * Incidence of new onset heart rhythm disorder during 6 months of follow-up
Interventions
Duration of intervention per patient/subject: 5 min, observation 6 months
Sponsors
Study design
Eligibility
Inclusion criteria
* outpatients after lung transplantation (single, double or combined) * outpatients on the wait list for lung transplantation
Exclusion criteria
* no informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation | 6 month |
Countries
Germany