Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients
QT long
1 other identifier
interventional
130
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2012
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 5, 2012
CompletedFirst Posted
Study publicly available on registry
December 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedOctober 5, 2016
October 1, 2016
6 years
December 5, 2012
October 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
to evaluate each test characteristics
Day 1
Study Arms (2)
patients with KCNQ1 or KCNH2 mutation
EXPERIMENTALpatients WITHOUT KCNQ1 or KCNH2 mutation (control group)
OTHERInterventions
Exercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms.
Epinephrine test : 1 hour after exercise test : epinephrine infusion during 20 minutes, and monitoring during 30 minutes after stop infusion with registering of electrocardiograms.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- QTc interval \>470msec
- Treatment interfering with cardiac repolarisation
- Under 15 years old
- Pregnant women
- Contraindication to exercise or epinephrine tests
- Patients without social coverage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Bordeaux Universitary Hospital
Bordeaux, 33604, France
Marseille Universitary Hospital
Marseille, 13385, France
CHU Montpellier
Montpellier, 34295, France
Nantes Universitary Hospital
Nantes, 44093, France
Rennes Universitary Hospital
Rennes, 35033, France
CHU Rouen
Rouen, 76031, France
CHU Toulouse
Toulouse, 31059, France
CHU Tours
Tours, 37170, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Eric DELANNOY, PH
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 5, 2012
First Posted
December 10, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
October 5, 2016
Record last verified: 2016-10