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

This study is currently recruiting participants.
Verified December 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01745666
First received: December 5, 2012
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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 Intervention
Long QT Syndrome Type 1 or 2
Other: exercise test
Other: Epinephrine test

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome. [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 130
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745666

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

Locations
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         
Sub-Investigator: Eric PEYROUSE, 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         
Sponsors and Collaborators
Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01745666     History of Changes
Other Study ID Numbers: RC11_0160
Study First Received: December 5, 2012
Last Updated: December 7, 2012
Health Authority: France: ANSM

Keywords provided by Nantes University Hospital:
Long QT syndrome, stress tests

Additional relevant MeSH terms:
Long QT Syndrome
Romano-Ward Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
Pathologic Processes
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 21, 2014