Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
720 participants
OBSERVATIONAL
2015-04-30
2016-07-31
Brief Summary
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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
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Detailed Description
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• 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Outpatients on the Waiting List and after Lung Transplantation
Electrocardiography
Electrocardiography
Duration of intervention per patient/subject:
5 min, observation 6 months
Interventions
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Electrocardiography
Duration of intervention per patient/subject:
5 min, observation 6 months
Eligibility Criteria
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Inclusion Criteria
* outpatients on the wait list for lung transplantation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Hannover Medical School
OTHER
Responsible Party
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Principal Investigators
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Jens Gottlieb, MD
Role: PRINCIPAL_INVESTIGATOR
Hannover MS, Dpt Respiratory Medicine
Locations
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Department of Respiratory Medicine, Medizinische Hochschule Hannover
Hanover, , Germany
Countries
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Central Contacts
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Other Identifiers
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2602-2015
Identifier Type: -
Identifier Source: org_study_id
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