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

October 4, 2016 updated by: Nantes University Hospital

Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients With KCNQ1 or KCNH2 Mutation Without Long QT Interval in Rest ECG

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Eric DELANNOY, PH

Study Locations

  • France
      • Bordeaux, France, 33604
        • Recruiting
        • Bordeaux Universitary Hospital
        • Contact:
        • Principal Investigator:
          • Frederic SACHER, PH
      • Marseille, France, 13385
        • Recruiting
        • Marseille Universitary Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Claude DEHARO, PU-PH
        • Principal Investigator:
          • Eric PEYROUSE, PH
      • Montpellier, France, 34295
      • Nantes, France, 44093
        • Recruiting
        • Nantes Universitary Hospital
        • Principal Investigator:
          • Vincent PROBST, PU-PH
      • Rennes, France, 35033
        • Recruiting
        • Rennes Universitary Hospital
        • Contact:
        • Principal Investigator:
          • Philippe MABO, PU-PH
      • Rouen, France, 76031
      • Toulouse, France, 31059
        • Recruiting
        • CHU Toulouse
        • Contact:
        • Principal Investigator:
          • Philippe MAURY, PH
      • Tours, France, 37170
        • Recruiting
        • Chu Tours
        • Contact:
        • Principal Investigator:
          • Dominique BABUTY, PU-PH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)).
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

May 1, 2018

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (ESTIMATE)

December 10, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 5, 2016

Last Update Submitted That Met QC Criteria

October 4, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC11_0160

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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