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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01745666
Other study ID # RC11_0160
Secondary ID
Status Recruiting
Phase N/A
First received December 5, 2012
Last updated October 4, 2016
Start date May 2012
Est. completion date May 2018

Study information

Verified date October 2016
Source Nantes University Hospital
Contact Vincent PROBST, PU-PH
Phone +33 2 40 16 57 00
Email vincent.probst@chu-nantes.fr
Is FDA regulated No
Health authority France: ANSM
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 130
Est. completion date May 2018
Est. primary completion date May 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 15 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

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

Locations

Country Name City State
France Bordeaux Universitary Hospital Bordeaux
France Marseille Universitary Hospital Marseille
France CHU Montpellier Montpellier
France Nantes Universitary Hospital Nantes
France Rennes Universitary Hospital Rennes
France CHU Rouen Rouen
France CHU Toulouse Toulouse
France CHU Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)). day 1 No
Secondary 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. Day 1 No