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Completed

NCT Number: NCT03291145

Exploring Mechanisms and Morphology of QT Interval Prolongation

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.

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Key information

Conditions

Long Qt Syndrome 1-2 Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Defects, Congenital Heart Diseases Long QT Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev-Gentofte Hospital

Herlev, Copenhagen, 2730, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

beta blockers

Drug

With and without Beta Blockers

Spironolactone

Drug

Brisk Standing before and after seven days treatment with Spironolactone

Primary outcomes

  1. QTc

    Time frame: 7 days

    Corrected QT

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Registry information

Official study title

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

Acronym: TriQarr

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 25, 2017
Registry last updated
Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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