NCT02380365

QT-Prolongation in Lung Transplantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 720 (estimated)
• Sponsor: Hannover Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Disorder Related to Lung Transplantation

Interventions

Type	Name	Description
DEVICE	Electrocardiography	Duration of intervention per patient/subject: 5 min, observation 6 months

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-04-01
• Completion: 2016-07-01
• First posted: 2015-03-05
• Last updated: 2015-03-05

Locations

1 site across 1 country: Germany