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Trial record 39 of 74 for:    "Andersen-Tawil syndrome" OR "Long QT Syndrome"

QT-Prolongation in Lung Transplantation (TX-QTC)

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ClinicalTrials.gov Identifier: NCT02380365
Recruitment Status : Unknown
Verified March 2015 by Hannover Medical School.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2015
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
Disorder Related to Lung Transplantation Device: Electrocardiography

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

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Study Type : Observational
Estimated Enrollment : 720 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: QT-Prolongation in Lung Transplantation
Study Start Date : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : July 2016


Group/Cohort Intervention/treatment
Outpatients on the Waiting List and after Lung Transplantation
Electrocardiography
Device: Electrocardiography

Duration of intervention per patient/subject:

5 min, observation 6 months





Primary Outcome Measures :
  1. prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Follow-up Patients after lung transplantation
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380365


Contacts
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Contact: Susanne Hoyer, MD 00495115324601 hoyer.susanne@mh-hannover.de
Contact: Jens Gottlieb, MD 00495115324681 gottlieb.jens@mh-hannover.de

Locations
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Germany
Department of Respiratory Medicine, Medizinische Hochschule Hannover
Hannover, Germany, 30625
Sponsors and Collaborators
Hannover Medical School
Investigators
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Principal Investigator: Jens Gottlieb, MD Hannover MS, Dpt Respiratory Medicine

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT02380365     History of Changes
Other Study ID Numbers: 2602-2015
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

Keywords provided by Hannover Medical School:
lung transplantation
electrocardiography
macrolides
QTc interval
arrhythmia

Additional relevant MeSH terms:
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Long QT Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes