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

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ClinicalTrials.gov Identifier: NCT01745666
Recruitment Status : Unknown
Verified October 2016 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : December 10, 2012
Last Update Posted : October 5, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Long QT Syndrome Type 1 or 2 Other: exercise test Other: Epinephrine test Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : May 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: patients with KCNQ1 or KCNH2 mutation Other: exercise test
Exercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms.

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.
patients WITHOUT KCNQ1 or KCNH2 mutation (control group) Other: exercise test
Exercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms.

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.


Outcome Measures
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Primary Outcome Measures :
  1. to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome. [ Time Frame: day 1 ]
    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 :
  1. to evaluate each test characteristics [ Time Frame: Day 1 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745666


Contacts
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Contact: Vincent PROBST, PU-PH +33 2 40 16 57 00 vincent.probst@chu-nantes.fr
Contact: Eric DELANNOY, PH

Locations
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France
Bordeaux Universitary Hospital Recruiting
Bordeaux, France, 33604
Contact: Frederic SACHER, PH    +33 5 57 65 64 71    frederic.sacher@chu-bordeaux.fr   
Principal Investigator: Frederic SACHER, PH         
Marseille Universitary Hospital Recruiting
Marseille, France, 13385
Contact: Jean-Claude DEHARO, PU-PH       jean-claude.deharo@ap-hm.fr   
Contact: Eric PEYROUSE, PH       eric.peyrouse@ap-hm.fr   
Principal Investigator: Jean-Claude DEHARO, PU-PH         
Principal Investigator: Eric PEYROUSE, PH         
CHU Montpellier Recruiting
Montpellier, France, 34295
Contact: Jean-Luc PASQUIE, PH       jl-pasquie@chu-montpellier.fr   
Principal Investigator: Jean-Luc PASQUIE, PH         
Nantes Universitary Hospital Recruiting
Nantes, France, 44093
Principal Investigator: Vincent PROBST, PU-PH         
Rennes Universitary Hospital Recruiting
Rennes, France, 35033
Contact: Philippe MABO, PU-PH       philippe.mabo@chu-rennes.fr   
Principal Investigator: Philippe MABO, PU-PH         
CHU Rouen Recruiting
Rouen, France, 76031
Contact: Frederic ANSELME, PH       frederic.anselme@chu-rouen.fr   
Principal Investigator: Frederic ANSELME, PH         
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Philippe MAURY, PH       maury.p@chu-toulouse.fr   
Principal Investigator: Philippe MAURY, PH         
CHU Tours Recruiting
Tours, France, 37170
Contact: BABUTY Dominique, PU-PH       d.babuty@chu-tours.fr   
Principal Investigator: Dominique BABUTY, PU-PH         
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01745666    
Other Study ID Numbers: RC11_0160
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: October 5, 2016
Last Verified: October 2016
Keywords provided by Nantes University Hospital:
Long QT syndrome, stress tests
Additional relevant MeSH terms:
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Long QT Syndrome
Romano-Ward Syndrome
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Epinephrine
Adrenergic alpha-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents