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CompletedNCT03291145TriQarrUpdated Feb 21, 2019

Exploring Mechanisms and Morphology of QT Interval Prolongation

An interventional study of Beta Blockers and Spironolactone in Long Qt Syndrome 1-2 and Sudden Cardiac Death, sponsored by Herlev and Gentofte Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-21.

Sponsored by Herlev and Gentofte Hospital · Not applicable, Interventional, and Prevention

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Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies in Death, Sudden, Cardiac with a site in Denmark — 2 open to participants now, 2 under way, none of them phase 3. Death, Sudden, Cardiac · Denmark.

Started
2017
the only one that year
No phase
7 of 11
2 open now
Registered
5th of 11
by date
Lead sponsor
2 of 11
Herlev and Gentofte Hospital

Among the 11 studies in Death, Sudden, Cardiac with a site in Denmark, this one is the only one that started in 2017, is one of 7 with no phase, and was the 5th registered.

Death, Sudden, Cardiac

363 studies on the registry are indexed under Death, Sudden, Cardiac; 84 are open to participants now.

Browse Death, Sudden, Cardiac studies →

Open to participants now

2 of the 11 studies in Death, Sudden, Cardiac with a site in Denmark are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →

Who these studies take

Of the 63 Death, Sudden, Cardiac studies recruiting now, 41 (65%) set no upper age limit and 11 (17%) stop at 75 or younger; 21 take children under 18; 7 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Long Qt Syndrome 1-2
  • Sudden Cardiac Death

Keywords

  • Long QT Syndrome
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Atrioventricular block,
  • Left bundle branch block,
  • Left ventricular hypertrophy,
  • Pace rhythm,
  • ST-deviations >1 mm),
  • \<50 % and significant valvulopathy,
  • Unstable psychiatric disease
  • Unstable cardiovascular disease.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    Beta Blockers

    With and without Beta Blockers

    Drug: Beta Blockers

  • Experimental
    Spironolactone

    With and without Spironolactone

    Drug: Spironolactone

Interventions

  • With and without Beta Blockers

  • Brisk Standing before and after seven days treatment with Spironolactone

06

What researchers measure

Primary outcomes

  1. QTc

    Corrected QT

    Time frame: 7 days

07

Study locations

1 site
  • Herlev-Gentofte Hospital
    Herlev, Copenhagen 2730, Denmark
08

References and documents

Publications

  • 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. PubMed 34531279 ↗
  • 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. PubMed 32882399 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Jun 2018, 12 months.

Of 47 non-industry interventional studies with no phase under Death, Sudden, Cardiac, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's 12 months is below that.

Counting every sponsor, half of 56 studies reached it within 42 months; a quarter within 17 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2017
First posted
Sep 25, 2017
StartActual
Jun 27, 2017
Primary completionActual
Jun 27, 2018
CompletionActual
Jan 1, 2019
Last update
Feb 21, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03291145
Lead sponsor
Herlev and Gentofte Hospital
Responsible party
Peter Marstrand (Medical Doctor, Research Fellow, Herlev and Gentofte Hospital) — Principal investigator
First posted
Sep 25, 2017
Start date
Jun 27, 2017
Primary completion
Jun 27, 2018
Completion
Jan 1, 2019
Last update
Feb 21, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Beta blockers · Spironolactone

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