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

Pfizer36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

ECT

Masking

NONE

Enrollment

Conditions

Patients With Pace Makers But no Evidence of Ischemic Heart Disease

Interventions

GTNDRUG

MoxifloxacinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with pace-makers but otherwise normal ventricular function Exclusion Criteria: * Nitrates, beta blockers

Locations (6)

Pfizer Investigational Site

Bruxelles (Brussels), Belgium

Pfizer Investigational Site

Glasgow, Scotland, United Kingdom

Pfizer Investigational Site

Leicester, United Kingdom

Pfizer Investigational Site

Liverpool, United Kingdom

Outcomes

Primary Outcomes

QT and QTc changes at two different pacing rates in atrially paced patients

Secondary Outcomes

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

Data from ClinicalTrials.gov

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