Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients

Long QT Syndrome Type 1 or 2 Clinical Trial

— QT long  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01745666
• Other study ID #: RC11_0160
• 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

Related Conditions & MeSH terms

• Long QT Syndrome
• Long QT Syndrome Type 1 or 2
• Romano-Ward Syndrome
• Syndrome

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