Left Bundle-Branch BlockEchoLBBBNCT04293471
Prediction of Outcome by Echocardiography in Left Bundle Branch Block
An observational study of Left Bundle-Branch Block, run by University Hospital of North Norway at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Left Bundle-Branch Block
- How many people
- 2,000 participants
- Where
- 1 siteNorway
- Study dates
- 15 Apr 2021to 31 Dec 2036
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- QRS complex >130 ms and R-wave duration in
- V6 >70 ms
- ventricular pacing>50%
- Previously implanted cardiac resynchronisation therapy (CRT)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
University Hospital North Norway
Tromsø, Troms, 9038
Assami Rösner, PhD, +4795990071, assami.rosner@unn.no
About this study
Official title: Prediction of Heart-failure and Mortality by Echocardiographic Parameters and Machine Learning in Individuals With Left Bundle Branch Block
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.
- Conditions
- Left Bundle-Branch Block
- Keywords
- Left bundle branch block, strain-imaging, myocardial work assessment, machine learning
- Medical subject headings
- Bundle-Branch Block
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death
Timepoint (day) of death and its cause
Measured: 15 years
Death of any cause
Timepoint (day) of death and its cause
Measured: 15 years
Secondary outcomes (1)
Hospital admission due to heart-failure
Time point of hospital admission and main-diagnosis
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start15 Apr 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Bundle-Branch BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University of Bergen, Norwegian University of Science and Technology, University of Tromso, KU Leuven
- Responsible party
- Principal investigator, Assami Rosner, University Hospital of North Norway
- Investigators
- Assami Rösner, MD,PhD, Principal investigator, University Hospital North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293471
- Sponsor's protocol ID
- REK2019/134
- Acronym
- EchoLBBB
- Status last verified
- May 2022
- First submitted
- 1 Mar 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Heart-failure and Mortality by Echocardiographic Parameters and Machine Learning in Individuals With Left Bundle Branch Block
- ClinicalTrials.gov ID
- NCT04293471
- Acronym / sponsor ID
- EchoLBBB / REK2019/134
- Conditions
- Left Bundle-Branch Block
- Keywords
- Left bundle branch block, strain-imaging, myocardial work assessment, machine learning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University of Bergen, Norwegian University of Science and Technology, University of Tromso, KU Leuven
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- QRS complex >130 ms and R-wave duration in
- V6 >70 ms
- ventricular pacing>50%
- Previously implanted cardiac resynchronisation therapy (CRT)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular death
Time frame: 15 years
Timepoint (day) of death and its cause
Death of any cause
Time frame: 15 years
Timepoint (day) of death and its cause
1 secondary outcome
Hospital admission due to heart-failure
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: 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
Related trials for Left Bundle-Branch Block
Active, not recruiting
REsynchronization Comparison In LBBB and Normal or Mildly Reduced VENTricular Function With CRT (REINVENT-CRT)
Left Ventricular Ejection Fraction, Heart Failure (HF)
Recruiting
Ambulatory Electrocardiographic Monitoring for the Detection of High-Degree Atrio-Ventricular Block in Patients With New-onset PeRsistent LEft Bundle Branch Block After Transcatheter Aortic Valve Implantation. The "MARE" Study
Aortic Valve Disease, Conduction Disturbances
Not yet recruiting
LBBAP Versus ILR in Patients With New-Onset LBBB and Moderately Reduced LVEF After TAVI
TAVI(Transcatheter Aortic Valve Implantation), Left Bundle Branch Block
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
Recruiting
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
Heart Failure, Systolic Bundle Branch Block, Left
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assami Rösner, MD,PhD principal investigator
University Hospital North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Bundle-Branch Block, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Assami Rösner, MD,PhD (04795990071, assami.rosner@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death (time frame: 15 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.