- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03291145
Exploring Mechanisms and Morphology of QT Interval Prolongation (TriQarr)
Exploring Mechanisms and Morphology of QT Interval Prolongation - An Inheritable as Well as an Inducible Phenomenon
The projects will try and optimise the risk stratification for patients with Long QT syndrome by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics tested by "Brisk Standing".
First, patients are tested with known arrhythmic triggers and they are then administered thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the patients are on Spironolactone for seven days. After seven days treatment the "Brisk Standing" is repeated.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the projects is to try and optimise the risk stratification for patients with Long QT syndrome by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics tested by "Brisk Standing".
First, patients are tested with known arrhythmic triggers and they are then administered thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the patients are on Spironolactone for seven days. After seven days treatment the "Brisk Standing" is repeated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Copenhagen
-
Herlev, Copenhagen, Denmark, 2730
- Herlev-Gentofte Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Verified Long QT syndrome mutation, subtype 1 or 2.
- over 18 years of age
Exclusion Criteria:
- Atrioventricular block,
- Left bundle branch block,
- Left ventricular hypertrophy,
- Pace rhythm,
- ST-deviations >1 mm),
- Left ventricular ejection fraction <50 % and significant valvulopathy,
- Unstable psychiatric disease
- Unstable cardiovascular disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beta Blockers
With and without Beta Blockers
|
With and without Beta Blockers
|
Experimental: Spironolactone
With and without Spironolactone
|
Brisk Standing before and after seven days treatment with Spironolactone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QTc
Time Frame: 7 days
|
Corrected QT
|
7 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Marstrand P, Almatlouh K, Kanters JK, Graff C, Christensen AH, Bundgaard H, Theilade J. Effect of moderate potassium-elevating treatment in long QT syndrome: the TriQarr Potassium Study. Open Heart. 2021 Sep;8(2):e001670. doi: 10.1136/openhrt-2021-001670.
- Marstrand P, Almatlouh K, Kanters JK, Graff C, Christensen AH, Bundgaard H, Theilade J. Long QT syndrome type 1 and 2 patients respond differently to arrhythmic triggers: The TriQarr in vivo study. Heart Rhythm. 2021 Feb;18(2):241-249. doi: 10.1016/j.hrthm.2020.08.017. Epub 2020 Aug 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Congenital Abnormalities
- Death, Sudden
- Arrhythmias, Cardiac
- Cardiac Conduction System Disease
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Heart Arrest
- Death
- Death, Sudden, Cardiac
- Long QT Syndrome
- Romano-Ward Syndrome
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Spironolactone
- Adrenergic beta-Antagonists
Other Study ID Numbers
- 260910000001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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