Long QT Syndrome Type 1 or 2QT longNCT01745666
Comparison Between Epinephrine and Exercise Test in QT Long Syndrome Patients
A study testing exercise test and Epinephrine test in people with Long QT Syndrome Type 1 or 2, run by Nantes University Hospital at 8 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Long QT Syndrome Type 1 or 2
- What is being tested?
- exercise test and Epinephrine test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 8 sitesFrance
- Study dates
- May 2012to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- QTc interval >470msec
- Treatment interfering with cardiac repolarisation
- Under 15 years old
- Pregnant women
- Contraindication to exercise or epinephrine tests
- Patients without social coverage
Trial locations and contacts
8 sites in 1 country.
Eric DELANNOY, PH contact
8 sites in 1 country
France8 sites, 8 recruiting
- Recruiting
Bordeaux Universitary Hospital
Bordeaux, 33604
Frederic SACHER, PH, +33 5 57 65 64 71, frederic.sacher@chu-bordeaux.fr
Frederic SACHER, PH
- Recruiting
Marseille Universitary Hospital
Marseille, 13385
Jean-Claude DEHARO, PU-PH, jean-claude.deharo@ap-hm.fr
Eric PEYROUSE, PH, eric.peyrouse@ap-hm.fr
- Recruiting
CHU Montpellier
Montpellier, 34295
Jean-Luc PASQUIE, PH, jl-pasquie@chu-montpellier.fr
Jean-Luc PASQUIE, PH
- Recruiting
Nantes Universitary Hospital
Nantes, 44093
Vincent PROBST, PU-PH
- Recruiting
Rennes Universitary Hospital
Rennes, 35033
Philippe MABO, PU-PH, philippe.mabo@chu-rennes.fr
Philippe MABO, PU-PH
- Recruiting
CHU Rouen
Rouen, 76031
Frederic ANSELME, PH, frederic.anselme@chu-rouen.fr
Frederic ANSELME, PH
- Recruiting
CHU Toulouse
Toulouse, 31059
Philippe MAURY, PH, maury.p@chu-toulouse.fr
Philippe MAURY, PH
- Recruiting
CHU Tours
Tours, 37170
BABUTY Dominique, PU-PH, d.babuty@chu-tours.fr
Dominique BABUTY, PU-PH
About this study
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
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.
Read the 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.
- Conditions
- Long QT Syndrome Type 1 or 2
- Being tested
- exercise test, Epinephrine test
- Keywords
- Long QT syndrome, stress tests
- Medical subject headings
- Romano-Ward Syndrome, Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise testOther
Exercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms.
Epinephrine testOther
Epinephrine test : 1 hour after exercise test : epinephrine infusion during 20 minutes, and monitoring during 30 minutes after stop infusion with registering of electrocardiograms.
| Study group | Role | What they receive |
|---|---|---|
| patients with KCNQ1 or KCNH2 mutation | Experimental | Not described Receives: Other: exercise test; Other: Epinephrine test |
| patients WITHOUT KCNQ1 or KCNH2 mutation (control group) | Other | Not described Receives: Other: exercise test; Other: Epinephrine test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
Measured: day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long QT Syndrome Type 1 or 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745666
- Sponsor's protocol ID
- RC11_0160
- Acronym
- QT long
- Status last verified
- Oct 2016
- First submitted
- 5 Dec 2012
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01745666
- Acronym / sponsor ID
- QT long / RC11_0160
- Conditions
- Long QT Syndrome Type 1 or 2
- Keywords
- Long QT syndrome, stress tests
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with KCNQ1 or KCNH2 mutation | Experimental | Other: exercise test, Other: Epinephrine test |
| patients WITHOUT KCNQ1 or KCNH2 mutation (control group) | Other | Other: exercise test, Other: Epinephrine test |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (6 listed)
- QTc interval >470msec
- Treatment interfering with cardiac repolarisation
- Under 15 years old
- Pregnant women
- Contraindication to exercise or epinephrine tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise testExercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms. | Other | patients WITHOUT KCNQ1 or KCNH2 mutation (control group), patients with KCNQ1 or KCNH2 mutation |
| Epinephrine testEpinephrine 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), patients with KCNQ1 or KCNH2 mutation |
Primary outcome
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)).
1 secondary outcome
to evaluate each test characteristics
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric DELANNOY, PH contact
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise test and Epinephrine test in people with Long QT Syndrome Type 1 or 2, run by Nantes University Hospital at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vincent PROBST, PU-PH (+33 2 40 16 57 00, vincent.probst@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the best stress exam (exercise test OR epinephrine test)to unmask long QT syndrome. (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.