Clinical Observational Registry of Patients With Left Bundle Branch Block

Recruiting

• Conditions: Left Bundle Branch Block (LBBB) on ECG

• Registration Number: NCT05283603
• Lead Sponsor: Azienda Ospedaliero Universitaria di Sassari

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-31
• Primary Completion: 2021-06-10
• Status Verified: 2022-02
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-12
• Last Update Submitted: 2022-03-12
• Study First Posted: 2022-03-17
• Last Update Posted: 2022-03-17
• Study Completion: 2029-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Left ventricular dysfunction	20 years	Echocardiographic left ventricular ejection fraction - EF (%)

Secondary Outcome Measures

Name	Time	Method
Adverse cardiovascular events (e.g., heart failure)	20 years	Heart failure (incidence and prevalence) Hospitalizations due to heart failure MACE

Trial Locations

Locations (1)

Cardiology, AOU Sassari; 🇮🇹 Sassari, Italy