Exploring Mechanisms and Morphology of QT Interval Prolongation

Sudden Cardiac Death Clinical Trial

— TriQarr  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291145
• Other study ID #: 260910000001
• Status: Completed
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: February 2019
• Source: Herlev and Gentofte Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 1, 2019
• Est. primary completion date: June 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Long QT Syndrome
• Long Qt Syndrome 1-2
• Romano-Ward Syndrome
• Sudden Cardiac Death

Intervention

Drug:
• Beta Blockers
With and without Beta Blockers
• Spironolactone
Brisk Standing before and after seven days treatment with Spironolactone

Locations

Country	Name	City	State
Denmark	Herlev-Gentofte Hospital	Herlev	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Herlev and Gentofte Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc	Corrected QT	7 days