QT-Prolongation in Lung Transplantation

Disorder Related to Lung Transplantation Clinical Trial

— TX-QTC  

Official title:

QT-Prolongation in Lung Transplantation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02380365
• Other study ID #: 2602-2015
• Status: Not yet recruiting
• Phase: N/A
• First received: March 2, 2015
• Last updated: March 2, 2015
• Start date: April 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2015
• Source: Hannover Medical School
• Contact: Susanne Hoyer, MD
• Phone: 00495115324601
• Email: hoyer.susanne[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 720
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disorder Related to Lung Transplantation
• Long QT Syndrome

Intervention

Device:
• Electrocardiography
Duration of intervention per patient/subject: 5 min, observation 6 months

Locations

Country	Name	City	State
Germany	Department of Respiratory Medicine, Medizinische Hochschule Hannover	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation		6 month	No