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Exploring Mechanisms and Morphology of QT Interval Prolongation (TriQarr)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03291145
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Marstrand, Herlev and Gentofte Hospital

Study Description
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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
Long Qt Syndrome 1-2 Sudden Cardiac Death Drug: Beta Blockers Drug: Spironolactone Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 27, 2017
Actual Primary Completion Date : June 27, 2018
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. QTc [ Time Frame: 7 days ]
    Corrected QT


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291145


Locations
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Denmark
Herlev-Gentofte Hospital
Herlev, Copenhagen, Denmark, 2730
Sponsors and Collaborators
Herlev and Gentofte Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Peter Marstrand, Medical Doctor, Research Fellow, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT03291145    
Other Study ID Numbers: 260910000001
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Marstrand, Herlev and Gentofte Hospital:
Long QT Syndrome
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Long QT Syndrome
Romano-Ward Syndrome
Death
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
 Spironolactone
Adrenergic beta-Antagonists
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action