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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03291145
Other study ID # 260910000001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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