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QT-Prolongation in Lung Transplantation

QT-Prolongation in Lung Transplantation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02380365
Acronym
TX-QTC
Enrollment
720
Registered
2015-03-05
Start date
2015-04-30
Completion date
2016-07-31
Last updated
2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder Related to Lung Transplantation

Keywords

lung transplantation, electrocardiography, macrolides, QTc interval, arrhythmia

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

Interventions

DEVICEElectrocardiography

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

Sponsors

Hannover Medical School
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* no informed consent

Design outcomes

Primary

MeasureTime frame
prevalence of significant QTc-interval prolongation (500 msec or above) after lung transplantation6 month

Countries

Germany

Contacts

Primary ContactSusanne Hoyer, MD
hoyer.susanne@mh-hannover.de00495115324601
Backup ContactJens Gottlieb, MD
gottlieb.jens@mh-hannover.de00495115324681

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026