Prediction of Outcome by Echocardiography in Left Bundle Branch Block

Left Bundle-Branch Block Clinical Trial

— EchoLBBB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04293471
• Other study ID #: REK2019/134
• Status: Recruiting
• Start date: April 15, 2021
• Est. completion date: December 31, 2036

Study information

• Verified date: May 2022
• Source: University Hospital of North Norway
• Contact: Assami Rösner, MD,PhD
• Phone: 04795990071
• Email: assami.rosner[@]unn.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. This study aims to identify echocardiographic parameters and ECG characteristics by machine learning in order to develop individual risk assessment

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2036
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Block
• Left Bundle-Branch Block

Locations

Country	Name	City	State
Norway	University Hospital North Norway	Tromsø	Troms

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital of North Norway	KU Leuven, Norwegian University of Science and Technology, Oslo University Hospital, University of Bergen, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Remodelling	Increase or decrease of ventricular volume in ml	5 years
Other	Cardiac function	Increase or decrease of ejection fraction in %	5 years
Other	Heart failure	Increase or decrease of heart failure by proBNP and NYHA class	5 years
Primary	Cardiovascular death	Timepoint (day) of death and its cause	15 years
Primary	Death of any cause	Timepoint (day) of death and its cause	15 years
Secondary	Hospital admission due to heart-failure	Time point of hospital admission and main-diagnosis	15 years