Exploring Mechanisms and Morphology of QT Interval Prolongation (TriQarr)

Herlev and Gentofte Hospital

Status: Completed

Conditions: Sudden Cardiac Death; Long Qt Syndrome 1-2

Treatments: Drug: Beta Blockers; Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT03291145

260910000001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Beta Blockers

Experimental group

Description:

With and without Beta Blockers

Treatment:

Drug: Beta Blockers

Spironolactone

Experimental group

Description:

With and without Spironolactone

Treatment:

Drug: Spironolactone