NCT02380365

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
720

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

March 2, 2015

Last Update Submit

March 2, 2015

Conditions

Disorder Related to Lung Transplantation

Keywords

lung transplantationelectrocardiographymacrolidesQTc intervalarrhythmia

Outcome Measures

Primary Outcomes (1)

  • prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation

    6 month

Study Arms (1)

Outpatients on the Waiting List and after Lung Transplantation

Electrocardiography

Device: Electrocardiography

Interventions

ElectrocardiographyDEVICE

Duration of intervention per patient/subject: 5 min, observation 6 months

Outpatients on the Waiting List and after Lung Transplantation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Follow-up Patients after lung transplantation

You may qualify if:

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

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Respiratory Medicine, Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Jens Gottlieb, MD

    Hannover MS, Dpt Respiratory Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susanne Hoyer, MD

CONTACT

00495115324601hoyer.susanne@mh-hannover.de

Jens Gottlieb, MD

CONTACT

00495115324681gottlieb.jens@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 5, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

DE(1)