Exploring Mechanisms and Morphology of QT Interval Prolon... | NCT03291145

Studies
Exploring Mechanisms and Morphology of QT Interval Prolongation

NCT03291145

Sponsor

Herlev and Gentofte Hospital

Status

Completed

Last Update Posted

Feb 21, 2019Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Long Qt Syndrome 1-2
Sudden Cardiac Death

Interventions

Beta Blockers
Spironolactone

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 27, 2017Actual

Primary Completion Date

Jun 27, 2018Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Aug 14, 2017

First Submission Date that Met QC Criteria

Sep 21, 2017

First Posted Date

Sep 25, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 20, 2019

Last Update Posted Date

Feb 21, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peter Marstrand, Medical Doctor, Research Fellow, Herlev and Gentofte HospitalPrincipal Investigator

Lead Sponsor

Herlev and Gentofte HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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".

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Beta Blockers	Experimental	With and without Beta Blockers	Drug: Beta Blockers
Spironolactone	Experimental	With and without Spironolactone	Drug: Spironolactone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beta Blockers	Drug	With and without Beta Blockers	Beta Blockers
Spironolactone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QTc	Corrected QT	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev-Gentofte Hospital		Herlev	Copenhagen	2730	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34531279	Derived	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.
32882399	Derived	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.

ID	Term
C566006	Long Qt Syndrome 1-2
D016757	Death, Sudden, Cardiac
D008133	Long QT Syndrome

ID	Term
D006323	Heart Arrest
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003645	Death, Sudden

ID	Term
D000319	Adrenergic beta-Antagonists
D013148	Spironolactone

ID	Term
D018674	Adrenergic Antagonists
D018663	Adrenergic Agents
D018377	Neurotransmitter Agents
D045504	Molecular Mechanisms of Pharmacological Action