Exploring Mechanisms and Morphology of QT Interval Prolongation

NCT ID: NCT03291145

Last Updated: 2019-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2019-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Long Qt Syndrome 1-2 Sudden Cardiac Death

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Beta Blockers

With and without Beta Blockers

Group Type EXPERIMENTAL

Beta Blockers

Intervention Type DRUG

With and without Beta Blockers

Spironolactone

With and without Spironolactone

Group Type EXPERIMENTAL

Spironolactone

Intervention Type DRUG

Brisk Standing before and after seven days treatment with Spironolactone

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Beta Blockers

With and without Beta Blockers

Intervention Type DRUG

Spironolactone

Brisk Standing before and after seven days treatment with Spironolactone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peter Marstrand

Medical Doctor, Research Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Herlev-Gentofte Hospital

Herlev, Copenhagen, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34531279 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32882399 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

260910000001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

LQT and Smartphone/Smartwatch
NCT04728100 COMPLETED