Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients

Nantes University Hospital130 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

130

Conditions

Long QT Syndrome Type 1 or 2

Interventions

exercise testOTHER

Exercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms.

Epinephrine testOTHER

Epinephrine test : 1 hour after exercise test : epinephrine infusion during 20 minutes, and monitoring during 30 minutes after stop infusion with registering of electrocardiograms.

Eligibility

Sex: ALLMin age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Bordeaux Universitary Hospital

Bordeaux, France

RECRUITING

Marseille Universitary Hospital

Marseille, France

RECRUITING

CHU Montpellier

Montpellier, France

Outcomes

Primary Outcomes

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

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)).

Time frame: day 1

Secondary Outcomes

to evaluate each test characteristics

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.

Time frame: Day 1

Central Contacts

Vincent PROBST, PU-PH

CONTACT

+33 2 40 16 57 00 vincent.probst@chu-nantes.fr

Eric DELANNOY, PH

CONTACT

Data from ClinicalTrials.gov

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