Clinical, Structural and Mechanical Features in Patients With Left Bundle Branch Block.

May 5, 2020 updated by: Leonardo Calò, MD, Policlinico Casilino ASL RMB

Clinical, Structural and Mechanical Features in Patients With Left Bundle Branch Block: an Observational and Prospective Study.

Clinical, structural and mechanical features in patients with left bundle branch block.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Left bundle-branch block (LBBB) is an electrocardiographic marker often associated with underlying cardiac disease (such as coronary artery disease, dilated cardiomyopathy, etc) but in some cases it is also found in patients with isolated LBBB defined as "none apparent structural heart disease".

Several investigations in animal and human study have showed a different electroanatomical activation in isolated LBBB when compared to LBBB in heart failure patients mostly due to coronary artery disease. The sequence of endocardial activation through the left ventricle has also proven to be heterogeneous in heart failure occuring at different septal regions. This electrical and mechanical variability seems to be related to location of LBBB block or lesion that could be proximal, distal or diffuse, consequently influencing also electrocardiographic aspects.

These considerations explain and justify the great variability in the proposed "true or typical LBBB" definitions (derived from from Strauss, Perrin and Marican definitions and from Heart Association/American College Cardiology Foundation/ European Society of Cardiology guidelines) but also shift attention to relatively new concept of atypical LBBB definitions with extreme left or right axis deviation and of non specific intraventricular conduction delay defined as a wide QRS (≥110 ms) without the appearance of left and right bundle-branch block. In fact, several investigations have shown that QRS axis deviation is a predictor of unfavorable outcome after cardiac resynchronization therapy and LBBB. The less favorable outcome of cardiac resynchronization therapy candidates with LBBB and left axis deviation seems to be associated to the presence of a shorter activation delay, scar tissue and left ventricular hypertrophy. Moreover, actual LBBB definitions recommended by guidelines in cardiac resynchronization therapy patients differ significantly and only individual ECG criteria (such as electrocardiographic intervals QS or RS in lead V1, notch and no q wave in lead V5, V6, I and avL) seems to be associated to clinical outcome when compared with combining criteria.

Finally, a frequent dyssynchrony of ventricular activation due to LBBB may be responsible for a dyssynchrony-related cardiomyopathy that needs to be identified early and differentiated from other forms of dilated cardiomyopathy through a multiparametric approach such as genetic, clinical data, electrocardiography and cardiac magnetic resonance. In fact, in isolated LBBB undergone cardiac magnetic resonance it was observed a greater left ventricular volumes and lower global left ventricular Ejection Fraction despite the absence of cardiovascular disease as compared with control subject. Despite this, comparison between isolated LBBB and structural heart disease shows a different myocardial mechanism all the more unfavourable the more significant is the presence of underlying myocardial scarring. In the other hand, isolated LBBB, dyssynchrony-related cardiomyopathy and myocardial scarring could present different temporal phase in the clinical history of the same patient and that must be early identified.

The aim of this present large-scale prospective observational study is to evaluate 1) clinical, electrocardiographic and imaging features in a population of patients with typical and atypical LBBB and " non specific intraventricular conduction delay" pattern during a long-term follow up and 2) association among eventual different LBBB patterns (typical, atypical (LBBB and extreme left and/or right axis deviation, fragmentation) and " non specific intraventricular conduction delay " pattern and tissue characterization, mechanical myocardial activation and perfusion. 3) a possible time-related evolution from "non specific intraventricular conduction delay" patterns to typical or atypical LBBB.

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Leonardo Calò, Professor
  • Phone Number: 0623188406

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

In this prospective observational study we consider to enroll patients with LBBB admitted to our Cardiology Department and Ambulatory Care Unit recording different ECG patterns, risk factors, genetic, underlying heart disease, imaging parameters (Echocardiographic and Cardiac Magnetic Resonance) and treatment (either pharmacological or interventional).

Description

Inclusion Criteria:

  • Every patient with electrocardiographic diagnosis of LBBB admitted to our Cardiology Department and Ambulatory Care Unit
  • ECG standard criteria from typical, atypical and NIVCD
  • Patients who have given their informed consent in writing.
  • Age ≥ 18 years

Exclusion Criteria:

  • Age <18 years
  • Patients who have not given their informed consent in writing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of ECG pattern distribution in LBBB patients
Time Frame: 5 years
5 years
Rate of underlying structural heart diseases in different LBBB pattern
Time Frame: 5 years
5 years
Number of participants with stress induced myocardial ischemia during Stress Magnetic resonance
Time Frame: 5 years
5 years
number or participants with late gadolinium enhancement during cardiac magnetic resonance
Time Frame: 5 years
5 years
number and of participants with isolated LBBB evolving to dyssynchrony-related cardiomyopathy
Time Frame: 5 years
5 years
Number of participants with mechanical dyssynchrony evaluated with Echocardiography
Time Frame: 5 years
Strain, Strain Rate, intraventricular timing Delay between left ventricular lateral and Septal wall
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico Casilino ASL RMB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 15, 2020

Primary Completion (Anticipated)

April 15, 2022

Study Completion (Anticipated)

April 15, 2025

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 28, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PoliclinicoCasilino

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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