QT-Prolongation in Lung Transplantation

• Conditions: Disorder Related to Lung Transplantation
• Interventions: Device: Electrocardiography

• Registration Number: NCT02380365
• Lead Sponsor: Hannover Medical School

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

Study Timeline

• Status Verified: 2015-03
• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-02
• Last Update Submitted: 2015-03-02
• Study First Posted: 2015-03-05
• Last Update Posted: 2015-03-05
• Study Start: 2015-04
• Primary Completion: 2016-04
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• outpatients after lung transplantation (single, double or combined)
• outpatients on the wait list for lung transplantation

Exclusion Criteria

• no informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Outpatients on the Waiting List and after Lung Transplantation	Electrocardiography	Electrocardiography

Primary Outcome Measures

Name	Time	Method
prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation	6 month

Trial Locations

Locations (1)

Department of Respiratory Medicine, Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany