QT-Prolongation in Lung Transplantation

NCT ID: NCT02380365

Last Updated: 2015-03-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

720 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-07-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Disorder Related to Lung Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Outpatients on the Waiting List and after Lung Transplantation

Electrocardiography

Electrocardiography

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* no informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

Central Contacts

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Susanne Hoyer, MD

Role: CONTACT

00495115324601

Jens Gottlieb, MD

Role: CONTACT

00495115324681

Other Identifiers

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2602-2015

Identifier Type: -

Identifier Source: org_study_id

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