Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients

Not Applicable

• Conditions: Long QT Syndrome Type 1 or 2
• Interventions: Other: exercise test; Other: Epinephrine test

• Registration Number: NCT01745666
• Lead Sponsor: Nantes University Hospital

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 Description

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-12-05
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-04
• Last Update Posted: 2016-10-05
• Primary Completion: 2018-05
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Patients with QTc<470 msec, and with molecular analysis (KCNQ1 or KCNH2 genes) performed in order to include 65 patients with KCNQ1 or KCNH2 mutation and 65 patients without KCNQ1 or KCNH2 mutation (controls).

Exclusion Criteria

• QTc interval >470msec
• Treatment interfering with cardiac repolarisation
• Under 15 years old
• Pregnant women
• Contraindication to exercise or epinephrine tests
• Patients without social coverage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients WITHOUT KCNQ1 or KCNH2 mutation (control group)	exercise test	-
patients with KCNQ1 or KCNH2 mutation	Epinephrine test	-
patients with KCNQ1 or KCNH2 mutation	exercise test	-
patients WITHOUT KCNQ1 or KCNH2 mutation (control group)	Epinephrine test	-

Primary Outcome Measures

Name	Time	Method
to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome.	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)).

Secondary Outcome Measures

Name	Time	Method
to evaluate each test characteristics	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.

Trial Locations

Locations (8)

Marseille Universitary Hospital; 🇫🇷 Marseille, France

Bordeaux Universitary Hospital; 🇫🇷 Bordeaux, France

Nantes Universitary Hospital; 🇫🇷 Nantes, France

CHU Montpellier; 🇫🇷 Montpellier, France

Rennes Universitary Hospital; 🇫🇷 Rennes, France

CHU Rouen; 🇫🇷 Rouen, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Tours; 🇫🇷 Tours, France