QT-Prolongation in Lung Transplantation | NCT02380365

Studies
QT-Prolongation in Lung Transplantation

NCT02380365

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Mar 5, 2015Estimated

Enrollment

720Estimated

Phase

Not provided

Conditions

Disorder Related to Lung Transplantation

Interventions

Electrocardiography

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 2016Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Mar 2, 2015

First Submission Date that Met QC Criteria

Mar 2, 2015

First Posted Date

Mar 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2015

Last Update Posted Date

Mar 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

720Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Outpatients on the Waiting List and after Lung Transplantation		Electrocardiography	Device: Electrocardiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Electrocardiography	Device	Duration of intervention per patient/subject: 5 min, observation 6 months	Outpatients on the Waiting List and after Lung Transplantation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Follow-up Patients after lung transplantation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Susanne Hoyer, MD	Contact	00495115324601		hoyer.susanne@mh-hannover.de
Jens Gottlieb, MD	Contact	00495115324681		gottlieb.jens@mh-hannover.de

Overall Officials

Name	Affiliation	Role
Jens Gottlieb, MD	Hannover MS, Dpt Respiratory Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Respiratory Medicine, Medizinische Hochschule Hannover		Hanover		30625	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004562	Electrocardiography

Ancestor Terms

ID	Term
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided