A Methodological Open Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarization and QT Interval At Fixed Heart Rate Under Autonomic Blockade

A Methodological Open-Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarisation and QT Interval At Fixed Heart Rate Under Autonomic Blockade

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00174512

Enrollment

Registered

2005-09-15

Start date

2005-03-31

Completion date

2006-06-30

Last updated

2006-11-08

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

Conditions

Patients With Pace Makers But no Evidence of Ischemic Heart Disease

Brief summary

To assess the effects of GTN on QT and QTc in subjects with And without atrial pacing. This will be done with and without autonomic blockade at two different pacing rates. Moxifloxacin effect on QT and QTc will also be assessed in atrially paced patients at two different pacing rates with and without autonomic blockade

Interventions

DRUGGTN

DRUGMoxifloxacin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

ECT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients with pace-makers but otherwise normal ventricular function

Exclusion criteria

* Nitrates, beta blockers

Design outcomes

Primary

Measure	Time frame
QT and QTc changes at two different pacing rates in atrially paced patients	—

Secondary

Measure	Time frame
Change in QT and QTcF before and after Moxifloxacin with and without autonomic blockade at each pacing rate Change in QT and QTcF before and after autonomic blockade at each pacing rate	—

Countries

Belgium, United Kingdom

Outcome results

None listed

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