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
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
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.
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cardiovascular death
Timepoint (day) of death and its cause
Time frame: 15 years
Death of any cause
Timepoint (day) of death and its cause
Time frame: 15 years
Hospital admission due to heart-failure
Time point of hospital admission and main-diagnosis
Time frame: 15 years
Remodelling
Increase or decrease of ventricular volume in ml
Time frame: 5 years
Cardiac function
Increase or decrease of ejection fraction in %
Time frame: 5 years
Heart failure
Increase or decrease of heart failure by proBNP and NYHA class
Time frame: 5 years
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.
Started Apr 2021 (actual). Primary completion is estimated for Dec 2027, 80 months after the start.
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