Prediction of Outcome by Echocardiography in Left Bundle Branch Block

NCT04293471 | Recruiting

• 1 other identifier: REK2019/134
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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

Conditions

Left Bundle-Branch Block

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Cardiovascular death

  Timepoint (day) of death and its cause

  15 years

• Death of any cause

  Timepoint (day) of death and its cause

  15 years

Secondary Outcomes (1)

• Hospital admission due to heart-failure

  15 years

Other Outcomes (3)

• Remodelling

  5 years

• Cardiac function

  5 years

• Heart failure

  5 years

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• QRS complex \>130 ms and R-wave duration in
• V6 \>70 ms
• ventricular pacing\>50%
• Previously implanted cardiac resynchronisation therapy (CRT)

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University Hospital North Norway

Tromsø, Troms, 9038, Norway

RECRUITING

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Assami Rösner, MD,PhD

  University Hospital North Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assami Rösner, MD,PhD

CONTACT

04795990071; assami.rosner@unn.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 3, 2020
• Study Start: April 15, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2036
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: 15 years
• Access Criteria: Patient have been included and five-year outcome data will have been revised.

Locations

NO (1)