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RecruitingNCT04293471EchoLBBBUpdated May 24, 2022

Prediction of Outcome by Echocardiography in Left Bundle Branch Block

An observational study in Left Bundle-Branch Block, sponsored by University Hospital of North Norway. Recruiting at 1 site in Norway. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by University Hospital of North Norway · Observational

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Patients with left bundle branch block have an increased risk for the development of heart-failure and death. However, risk factors for unfavorable outcomes are still poorly defined. This study aims to identify echocardiographic parameters and ECG characteristics by machine learning in order to develop individual risk assessment

Read the detailed description

The project investigates patients with left bundle branch block (LBBB) which describes a specific block in the electrical conduction system, where the electrical impulses must follow a detour, with the result that different parts of the heart-muscle do not contract at the same time. This condition is called left ventricular dyssynchrony. LBBB can be found in people who are otherwise completely healthy and need not have any practical consequences. In others LBBB is present in patients with different heart diseases such as after myocardial infarctions or other diseases involving the heart-muscle. Patients with implanted pacemakers have a similar failure in the conduction system. Both conditions can increase the risk for development of heart-failure and cardiovascular death. Dyssynchrony can be treated with a special pacemaker (cardiac resynchronisation therapy, CRT) in addition to regular medical treatment. The therapy is well established and has shown to reduce morbidity and mortality and even reverse heart-failure in some patients completely. However, the patients in need and responding to CRT treatment is still not optimally defined. New echocardiographic parameters based on strain imaging such as regional myocardial work are able quantify the degree of dyssynchrony and give new insights into the interplay of activation delay through the LBBB and loading conditions and weakness of the myocardium due to other diseases. These new and complex measures can be integrated with clinical information by machine learning (ML) as a promising tools for accurate patient selection for CRT. The project aims to find markers on ultrasound improved by ML based selection to distinguish those patients who have problems associated with the branch block from those who remain stable. This will facilitate both, an optimized patient selection for CRT treatment and follow-up schedule for those who have a stable condition.

02

Conditions studied

  • Left Bundle-Branch Block

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Keywords

  • Left bundle branch block
  • strain-imaging
  • myocardial work assessment
  • machine learning
03

In context

Bundle-Branch Block

94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 162 across 33 observational studies indexed under Bundle-Branch Block.

Browse Bundle-Branch Block studies →

Lead sponsor

University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients will be recruited based on epidemiological studies from Tromsø, where LBBB or ventricular pacing has been identified. Further in-hospital patients and patients from the out-patient clinics will be recruited due to ECG assessment

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

  • QRS complex >130 ms and R-wave duration in
  • V6 >70 ms
  • ventricular pacing>50%
  • Previously implanted cardiac resynchronisation therapy (CRT)

Exclusion criteria

Exclusion Criteria:

  • Typical right bundle branch block.
  • No ability to give ,
  • non-cardiovascular co-mobidities with reduced life-expectancy \< 1 year
  • patients with complex congenital heart disease.
Terms in these criteria, in plain language(1)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
15 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Cardiovascular death

    Timepoint (day) of death and its cause

    Time frame: 15 years

  2. Death of any cause

    Timepoint (day) of death and its cause

    Time frame: 15 years

Secondary outcomes

  1. Hospital admission due to heart-failure

    Time point of hospital admission and main-diagnosis

    Time frame: 15 years

Other outcomes

  1. Remodelling

    Increase or decrease of ventricular volume in ml

    Time frame: 5 years

  2. Cardiac function

    Increase or decrease of ejection fraction in %

    Time frame: 5 years

  3. Heart failure

    Increase or decrease of heart failure by proBNP and NYHA class

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — All individual analytic codes for participants fom other Norwegian Hospitals need to be transferred to University Hospital North Norway (UNN) for registering outcome follow-up

Supporting information: Study protocol, Informed consent form, Clinical study report, Analytic code

Time frame: 15 years

Access criteria: Patient have been included and five-year outcome data will have been revised.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2021 (actual). Primary completion is estimated for Dec 2027, 80 months after the start.

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

Registered
Mar 1, 2020
First posted
Mar 3, 2020
StartActual
Apr 15, 2021
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2036
Last update
May 24, 2022
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 May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04293471
Responsible party
Assami Rosner (MD PhD, University Hospital of North Norway) — Principal investigator
First posted
Mar 3, 2020
Start date
Apr 15, 2021
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2036 (estimated)
Last update
May 24, 2022

Study contacts

Assami Rösner, MD,PhD
Contact
assami.rosner@unn.no
04795990071
Assami Rösner, MD,PhD
principal investigator · University Hospital North Norway

Oversight

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

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