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Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients (QT long)

Primary Purpose

Long QT Syndrome Type 1 or 2

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
exercise test
Epinephrine test
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Long QT Syndrome Type 1 or 2 focused on measuring Long QT syndrome, stress tests

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Bordeaux Universitary HospitalRecruiting
  • Marseille Universitary HospitalRecruiting
  • CHU MontpellierRecruiting
  • Nantes Universitary HospitalRecruiting
  • Rennes Universitary HospitalRecruiting
  • CHU RouenRecruiting
  • CHU ToulouseRecruiting
  • CHU ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

patients with KCNQ1 or KCNH2 mutation

patients WITHOUT KCNQ1 or KCNH2 mutation (control group)

Arm Description

Outcomes

Primary Outcome Measures

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)).

Secondary Outcome Measures

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.

Full Information

First Posted
December 5, 2012
Last Updated
October 4, 2016
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01745666
Brief Title
Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long QT Syndrome Type 1 or 2
Keywords
Long QT syndrome, stress tests

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with KCNQ1 or KCNH2 mutation
Arm Type
Experimental
Arm Title
patients WITHOUT KCNQ1 or KCNH2 mutation (control group)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
exercise test
Intervention Description
Exercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms.
Intervention Type
Other
Intervention Name(s)
Epinephrine test
Intervention Description
Epinephrine test : 1 hour after exercise test : epinephrine infusion during 20 minutes, and monitoring during 30 minutes after stop infusion with registering of electrocardiograms.
Primary Outcome Measure Information:
Title
to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome.
Description
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 Outcome Measure Information:
Title
to evaluate each test characteristics
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent PROBST, PU-PH
Phone
+33 2 40 16 57 00
Email
vincent.probst@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Eric DELANNOY, PH
Facility Information:
Facility Name
Bordeaux Universitary Hospital
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic SACHER, PH
Phone
+33 5 57 65 64 71
Email
frederic.sacher@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Frederic SACHER, PH
Facility Name
Marseille Universitary Hospital
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Claude DEHARO, PU-PH
Email
jean-claude.deharo@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Eric PEYROUSE, PH
Email
eric.peyrouse@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Jean-Claude DEHARO, PU-PH
First Name & Middle Initial & Last Name & Degree
Eric PEYROUSE, PH
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc PASQUIE, PH
Email
jl-pasquie@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Jean-Luc PASQUIE, PH
Facility Name
Nantes Universitary Hospital
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent PROBST, PU-PH
Facility Name
Rennes Universitary Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MABO, PU-PH
Email
philippe.mabo@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Philippe MABO, PU-PH
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frederic ANSELME, PH
Email
frederic.anselme@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Frederic ANSELME, PH
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe MAURY, PH
Email
maury.p@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Philippe MAURY, PH
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37170
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BABUTY Dominique, PU-PH
Email
d.babuty@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
Dominique BABUTY, PU-PH

12. IPD Sharing Statement

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Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients

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