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Exploring Mechanisms and Morphology of QT Interval Prolongation (TriQarr)

Primary Purpose

Long Qt Syndrome 1-2, Sudden Cardiac Death

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Beta Blockers

Spironolactone

About this trial

This is an interventional prevention trial for Long Qt Syndrome 1-2 focused on measuring Long QT Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Herlev-Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Beta Blockers

Spironolactone

Arm Description

With and without Beta Blockers

With and without Spironolactone

Outcomes

Primary Outcome Measures

QTc

Corrected QT

Secondary Outcome Measures

Full Information

NCT ID

NCT03291145

First Posted

August 14, 2017

Last Updated

February 20, 2019

Sponsor

Herlev and Gentofte Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03291145

Brief Title

Exploring Mechanisms and Morphology of QT Interval Prolongation

Acronym

TriQarr

Official Title

Exploring Mechanisms and Morphology of QT Interval Prolongation - An Inheritable as Well as an Inducible Phenomenon

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

June 27, 2017 (Actual)

Primary Completion Date

June 27, 2018 (Actual)

Study Completion Date

January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herlev and Gentofte Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Long Qt Syndrome 1-2, Sudden Cardiac Death

Keywords

Long QT Syndrome

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Beta Blockers

Arm Type

Experimental

Arm Description

With and without Beta Blockers

Arm Title

Spironolactone

Arm Type

Experimental

Arm Description

With and without Spironolactone

Intervention Type

Drug

Intervention Name(s)

Beta Blockers

Intervention Description

With and without Beta Blockers

Intervention Type

Drug

Intervention Name(s)

Spironolactone

Intervention Description

Brisk Standing before and after seven days treatment with Spironolactone

Primary Outcome Measure Information:

Title

QTc

Description

Corrected QT

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Herlev-Gentofte Hospital

City

Herlev

State/Province

Copenhagen

ZIP/Postal Code

2730

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

34531279

Citation

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.

Results Reference

derived

PubMed Identifier

32882399

Citation

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.

Results Reference

derived

Learn more about this trial

Exploring Mechanisms and Morphology of QT Interval Prolongation

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