Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients

NCT ID: NCT01745666

Last Updated: 2016-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Long QT Syndrome Type 1 or 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patients with KCNQ1 or KCNH2 mutation

Group Type EXPERIMENTAL

exercise test

Intervention Type OTHER

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

Epinephrine test

Intervention Type OTHER

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

patients WITHOUT KCNQ1 or KCNH2 mutation (control group)

Group Type OTHER

exercise test

Intervention Type OTHER

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

Epinephrine test

Intervention Type OTHER

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

Interventions

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exercise test

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

Intervention Type OTHER

Epinephrine test

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bordeaux Universitary Hospital

Bordeaux, , France

Site Status RECRUITING

Marseille Universitary Hospital

Marseille, , France

Site Status RECRUITING

CHU Montpellier

Montpellier, , France

Site Status RECRUITING

Nantes Universitary Hospital

Nantes, , France

Site Status RECRUITING

Rennes Universitary Hospital

Rennes, , France

Site Status RECRUITING

CHU Rouen

Rouen, , France

Site Status RECRUITING

CHU Toulouse

Toulouse, , France

Site Status RECRUITING

CHU Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Vincent PROBST, PU-PH

Role: CONTACT

+33 2 40 16 57 00

Eric DELANNOY, PH

Role: CONTACT

Facility Contacts

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Frederic SACHER, PH

Role: primary

+33 5 57 65 64 71

Jean-Claude DEHARO, PU-PH

Role: primary

Eric PEYROUSE, PH

Role: backup

Jean-Luc PASQUIE, PH

Role: primary

Philippe MABO, PU-PH

Role: primary

Frederic ANSELME, PH

Role: primary

Philippe MAURY, PH

Role: primary

BABUTY Dominique, PU-PH

Role: primary

Other Identifiers

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RC11_0160

Identifier Type: -

Identifier Source: org_study_id

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