NCT03291145

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

August 14, 2017

Last Update Submit

February 20, 2019

Conditions

Keywords

Long QT Syndrome

Outcome Measures

Primary Outcomes (1)

  • QTc

    Corrected QT

    7 days

Study Arms (2)

Beta Blockers

EXPERIMENTAL

With and without Beta Blockers

Drug: Beta Blockers

Spironolactone

EXPERIMENTAL

With and without Spironolactone

Drug: Spironolactone

Interventions

With and without Beta Blockers

Beta Blockers

Brisk Standing before and after seven days treatment with Spironolactone

Spironolactone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Verified Long QT syndrome mutation, subtype 1 or 2.
  • over 18 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev-Gentofte Hospital

Herlev, Copenhagen, 2730, Denmark

Location

Related Publications (2)

  • Marstrand P, Almatlouh K, Kanters JK, Graff C, Christensen AH, Bundgaard H, Theilade J. Effect of moderate potassium-elevating treatment in long QT syndrome: the TriQarr Potassium Study. Open Heart. 2021 Sep;8(2):e001670. doi: 10.1136/openhrt-2021-001670.

  • Marstrand P, Almatlouh K, Kanters JK, Graff C, Christensen AH, Bundgaard H, Theilade J. Long QT syndrome type 1 and 2 patients respond differently to arrhythmic triggers: The TriQarr in vivo study. Heart Rhythm. 2021 Feb;18(2):241-249. doi: 10.1016/j.hrthm.2020.08.017. Epub 2020 Aug 31.

MeSH Terms

Conditions

Long Qt Syndrome 1-2Death, Sudden, CardiacLong QT Syndrome

Interventions

Adrenergic beta-AntagonistsSpironolactone

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and SymptomsArrhythmias, CardiacCardiac Conduction System DiseaseHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Adrenergic AntagonistsAdrenergic AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsLactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Research Fellow

Study Record Dates

First Submitted

August 14, 2017

First Posted

September 25, 2017

Study Start

June 27, 2017

Primary Completion

June 27, 2018

Study Completion

January 1, 2019

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations