QT-Prolongation in Lung Transplantation (TX-QTC)

March 2, 2015 updated by: Hannover Medical School

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

720

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Hannover, Germany, 30625
        • Department of Respiratory Medicine, Medizinische Hochschule Hannover

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Follow-up Patients after lung transplantation

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Jens Gottlieb, MD, Hannover MS, Dpt Respiratory Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

March 2, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 5, 2015

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2602-2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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