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Prediction of Outcome by Echocardiography in Left Bundle Branch Block

Prediction of Heart-failure and Mortality by Echocardiographic Parameters and Machine Learning in Individuals With Left Bundle Branch Block

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04293471
Acronym
EchoLBBB
Enrollment
2000
Registered
2020-03-03
Start date
2021-04-15
Completion date
2036-12-31
Last updated
2022-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Left Bundle-Branch Block

Keywords

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

Brief 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

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.

Interventions

None listed

Sponsors

Oslo University Hospital
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Norwegian University of Science and Technology
CollaboratorOTHER
University of Tromso
CollaboratorOTHER
KU Leuven
CollaboratorOTHER
University Hospital of North Norway
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

* Typical right bundle branch block. * No ability to give informed consent, * non-cardiovascular co-mobidities with reduced life-expectancy \< 1 year * patients with complex congenital heart disease.

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular death15 yearsTimepoint (day) of death and its cause
Death of any cause15 yearsTimepoint (day) of death and its cause

Secondary

MeasureTime frameDescription
Hospital admission due to heart-failure15 yearsTime point of hospital admission and main-diagnosis

Other

MeasureTime frameDescription
Remodelling5 yearsIncrease or decrease of ventricular volume in ml
Cardiac function5 yearsIncrease or decrease of ejection fraction in %
Heart failure5 yearsIncrease or decrease of heart failure by proBNP and NYHA class

Countries

Norway

Contacts

Primary ContactAssami Rösner, MD,PhD
assami.rosner@unn.no04795990071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026