Disorder Related to Lung TransplantationTX-QTCNCT02380365
QT-Prolongation in Lung Transplantation
An observational study of Disorder Related to Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder Related to Lung Transplantation
- What is being tested?
- Electrocardiography
- Type of treatment
- Medical device
- How many people
- 720 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Follow-up Patients after lung transplantation
Who may be able to join
- outpatients after lung transplantation (single, double or combined)
- outpatients on the wait list for lung transplantation
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Respiratory Medicine, Medizinische Hochschule Hannover
Hanover, 30625
About this study
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
Read the 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
- Conditions
- Disorder Related to Lung Transplantation
- Being tested
- Electrocardiography
- Keywords
- lung transplantation, electrocardiography, macrolides, QTc interval, arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectrocardiographyDevice
Duration of intervention per patient/subject:
5 min, observation 6 months
| Study group | Role | What they receive |
|---|---|---|
| Outpatients on the Waiting List and after Lung Transplantation | Electrocardiography Receives: Device: Electrocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionApr 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder Related to Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens Gottlieb, MD, Principal investigator, Hannover MS, Dpt Respiratory Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380365
- Sponsor's protocol ID
- 2602-2015
- Acronym
- TX-QTC
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QT-Prolongation in Lung Transplantation
- ClinicalTrials.gov ID
- NCT02380365
- Acronym / sponsor ID
- TX-QTC / 2602-2015
- Conditions
- Disorder Related to Lung Transplantation
- Keywords
- lung transplantation, electrocardiography, macrolides, QTc interval, arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 5 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatients on the Waiting List and after Lung Transplantation | – | Device: ElectrocardiographyElectrocardiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Follow-up Patients after lung transplantation
Key inclusion criteria (2 listed)
- outpatients after lung transplantation (single, double or combined)
- outpatients on the wait list for lung transplantation
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectrocardiographyDuration of intervention per patient/subject: 5 min, observation 6 months | Device | Outpatients on the Waiting List and after Lung Transplantation |
Primary outcome
prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Gottlieb, MD principal investigator
Hannover MS, Dpt Respiratory Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disorder Related to Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanne Hoyer, MD (00495115324601, hoyer.susanne@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2015.