Exploring Mechanisms and Morphology of QT Interval Prolongation
TriQarr
1 other identifier
interventional
28
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
1 active site
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
June 27, 2017
CompletedFirst Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
September 25, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFebruary 21, 2019
February 1, 2019
1 year
August 14, 2017
February 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
QTc
Corrected QT
7 days
Study Arms (2)
Beta Blockers
EXPERIMENTALWith and without Beta Blockers
Spironolactone
EXPERIMENTALWith and without Spironolactone
Interventions
Brisk Standing before and after seven days treatment with Spironolactone
Eligibility Criteria
You may qualify if:
- Verified Long QT syndrome mutation, subtype 1 or 2.
- over 18 years of age
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Herlev-Gentofte Hospital
Herlev, Copenhagen, 2730, Denmark
Related Publications (2)
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.
PMID: 34531279DERIVEDMarstrand 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.
PMID: 32882399DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor, Research Fellow
Study Record Dates
First Submitted
August 14, 2017
First Posted
September 25, 2017
Study Start
June 27, 2017
Primary Completion
June 27, 2018
Study Completion
January 1, 2019
Last Updated
February 21, 2019
Record last verified: 2019-02