EchoLBBB: Prediction of Outcome by Echocardiography in Left Bundle Branch Block

Sponsor
University Hospital of North Norway (Other)
Overall Status
Recruiting
CT.gov ID
NCT04293471
Collaborator
Oslo University Hospital (Other), University of Bergen (Other), Norwegian University of Science and Technology (Other), University of Tromso (Other), KU Leuven (Other)
2,000
1
188.6
10.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Heart-failure and Mortality by Echocardiographic Parameters and Machine Learning in Individuals With Left Bundle Branch Block
    Actual Study Start Date :
    Apr 15, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2027
    Anticipated Study Completion Date :
    Dec 31, 2036

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular death [15 years]

      Timepoint (day) of death and its cause

    2. Death of any cause [15 years]

      Timepoint (day) of death and its cause

    Secondary Outcome Measures

    1. Hospital admission due to heart-failure [15 years]

      Time point of hospital admission and main-diagnosis

    Other Outcome Measures

    1. Remodelling [5 years]

      Increase or decrease of ventricular volume in ml

    2. Cardiac function [5 years]

      Increase or decrease of ejection fraction in %

    3. Heart failure [5 years]

      Increase or decrease of heart failure by proBNP and NYHA class

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital North Norway Tromsø Troms Norway 9038

    Sponsors and Collaborators

    • University Hospital of North Norway
    • Oslo University Hospital
    • University of Bergen
    • Norwegian University of Science and Technology
    • University of Tromso
    • KU Leuven

    Investigators

    • Principal Investigator: Assami Rösner, MD,PhD, University Hospital North Norway

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Assami Rosner, MD PhD, University Hospital of North Norway
    ClinicalTrials.gov Identifier:
    NCT04293471
    Other Study ID Numbers:
    • REK2019/134
    First Posted:
    Mar 3, 2020
    Last Update Posted:
    May 24, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Assami Rosner, MD PhD, University Hospital of North Norway
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 24, 2022