Clinical Observational Registry of Patients With Left Bundle Branch Block (RECOrd-LBBB)

March 12, 2022 updated by: Giuseppe Damiano Sanna, Azienda Ospedaliero Universitaria di Sassari

Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra

The electromechanical dyssynchrony induced by the presence of LBBB is in some patients, but not all, the cause of progressive left ventricular systolic dysfunction and heart failure.

Aims

  1. To investigate the clinical, ECG, imaging-derived features in a large cohort of patients affected by LBBB on ECG.
  2. To identify predictors of LBBB-induced LV systolic dysfunction and predictors of outcome in this population.
  3. To derive data which may have an impact on therapeutic management.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

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: Giuseppe D Sanna, MD PhD
  • Phone Number: +39 0792061561

Study Locations

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

Patients with LBBB

Description

Inclusion Criteria:

  • LBBB on ECG

Exclusion Criteria:

  • Previous extensive anterior myocardial infarction
  • Previous cardiac surgery or transcatheter aortic valve implantation (TAVI)
  • Congenital structural heart disease
  • Patients implanted with permanent right ventricular stimulation devices and permanent pacing
  • Denial to consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular dysfunction
Time Frame: 20 years
Echocardiographic left ventricular ejection fraction - EF (%)
20 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse cardiovascular events (e.g., heart failure)
Time Frame: 20 years
Heart failure (incidence and prevalence) Hospitalizations due to heart failure MACE
20 years

Collaborators and Investigators

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

Sponsor

Azienda Ospedaliero Universitaria di Sassari

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 (Actual)

July 31, 2019

Primary Completion (Actual)

June 10, 2021

Study Completion (Anticipated)

July 31, 2029

Study Registration Dates

First Submitted

February 25, 2022

First Submitted That Met QC Criteria

March 12, 2022

First Posted (Actual)

March 17, 2022

Study Record Updates

Last Update Posted (Actual)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 12, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PG/2019/8862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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