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ClinicalTrials.gov ID

NCT01745666

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

130Estimated

Last Update Posted

Oct 5, 2016Estimated

Start Date

May 2012

Primary Completion Date

May 2018Estimated

Completion Date

May 2018Estimated

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 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.

• Long QT Syndrome Type 1 or 2

• exercise test
• Epinephrine test

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

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

Primary Purpose

Diagnostic

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Nantes University HospitalOTHER

frederic.anselme@chu-rouen.fr

d.babuty@chu-tours.fr