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QT-Prolongation in Lung Transplantation (TX-QTC)

H

Hannover Medical School (MHH)

Status

Unknown

Conditions

Disorder Related to Lung Transplantation

Treatments

Device: Electrocardiography

Study type

Observational

Funder types

Other

Identifiers

NCT02380365
2602-2015

Details and patient eligibility

About

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

Full 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

Enrollment

720 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • no informed consent

Trial design

720 participants in 1 patient group

Outpatients on the Waiting List and after Lung Transplantation
Description:
Electrocardiography
Treatment:
Device: Electrocardiography

Trial contacts and locations

1

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Central trial contact

Jens Gottlieb, MD; Susanne Hoyer, MD

Data sourced from clinicaltrials.gov

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