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TriQarr: Exploring Mechanisms and Morphology of QT Interval Prolongation

Sponsor
Herlev and Gentofte Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03291145
Collaborator
(none)
28
Enrollment
1
Location
2
Arms
18.2
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Exploring Mechanisms and Morphology of QT Interval Prolongation - An Inheritable as Well as an Inducible Phenomenon
Actual Study Start Date :
Jun 27, 2017
Actual Primary Completion Date :
Jun 27, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Beta Blockers

With and without Beta Blockers

Drug: Beta Blockers
With and without Beta Blockers
Experimental: Spironolactone

With and without Spironolactone

Drug: Spironolactone
Brisk Standing before and after seven days treatment with Spironolactone

Outcome Measures

Primary Outcome Measures

  1. QTc [7 days]

    Corrected QT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Herlev-Gentofte Hospital Herlev Copenhagen Denmark 2730

Sponsors and Collaborators

  • Herlev and Gentofte Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Marstrand, Medical Doctor, Research Fellow, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier:
NCT03291145
Other Study ID Numbers:
  • 260910000001
First Posted:
Sep 25, 2017
Last Update Posted:
Feb 21, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peter Marstrand, Medical Doctor, Research Fellow, Herlev and Gentofte Hospital
Long QT Syndrome
Additional relevant MeSH terms:
Death, Sudden, Cardiac
Long QT Syndrome
Romano-Ward Syndrome
Death
Spironolactone
Adrenergic beta-Antagonists

Study Results

No Results Posted as of Feb 21, 2019