Clinical Trial: Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients With KCNQ1 or KCNH2 Mutation Without Long QT Interval in Rest ECG

Brief Summary: The aim of the study is to evaluate the best stress exam to unmask long QT in patient with KCNQ1 or KCNH2 mutation without long QT interval in rest electrocardiogram.

Detailed Summary:

65 patients with KCNQ1 or KCNH2 mutation presenting QTc interval <470msec and 65 patients without KCNQ1 or KCNH2 mutation presenting QTc interval <470msec will be included.

All patients will have the 2 tests: exercise test and epinephrine test, in one half day.

At the end of the inclusions, two experts will examine examens results without knowing in which arm (mutated or not) the patient belongs.


Sponsor: Nantes University Hospital

Current Primary Outcome: to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome. [ Time Frame: day 1 ]

Exercise test and epinephrine test will be done at inclusion (day 1). The primary outcome of this study is to evaluate the best stress exam (exercise test versus epinephrine test), defined by a "positive" test to unmask long QT syndrome. Test is positive when QT interval lengthens 30 ms At the end of study inclusions, two reviewers will analyse, independently, electrocardiograms resulting from these tests to determine for each patient if a test was positive and which one. These reviewers will do this job without being informed of the patient status (mutated patient or not mutated patient (control)).


Original Primary Outcome: Same as current

Current Secondary Outcome: to evaluate each test characteristics [ Time Frame: Day 1 ]

Exercise test and epinephrine test will be done at inclusion (day 1). The secondary outcome is to evaluate each test (exercise test and epinephrine test) characteristics. At the end of study inclusions, two reviewers will independently analyse electrocardiograms resulting from these tests to evaluate their characteristics.


Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: December 5, 2012
Date Started: May 2012
Date Completion: May 2018
Last Updated: October 4, 2016
Last Verified: October 2016