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QT-Prolongation in Lung Transplantation — TX-QTC  

Disorder Related to Lung Transplantation Clinical Trial

Official title:
QT-Prolongation in Lung Transplantation

Clinical Trial 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

Clinical Trial 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 ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02380365
Study type Observational
Source Hannover Medical School
Contact Susanne Hoyer, MD
Phone 00495115324601
Email hoyer.susanne@mh-hannover.de
Status Not yet recruiting
Phase N/A
Start date April 2015
Completion date July 2016
View Details
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