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

• Sponsor: Azienda Ospedaliero Universitaria di Sassari (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05283603
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Left Bundle Branch Block (LBBB) on ECG	Diagnostic Test: ECG, Echocardiogram, Magnetic resonance

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra
• Actual Study Start Date: Jul 31, 2019
• Actual Primary Completion Date: Jun 10, 2021
• Anticipated Study Completion Date: Jul 31, 2029

Outcome Measures

Primary Outcome Measures

1. Left ventricular dysfunction [20 years]

   Echocardiographic left ventricular ejection fraction - EF (%)

Secondary Outcome Measures

1. Adverse cardiovascular events (e.g., heart failure) [20 years]

   Heart failure (incidence and prevalence) Hospitalizations due to heart failure MACE

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiology, AOU Sassari	Sassari		Italy	07100

Sponsors and Collaborators

• Azienda Ospedaliero Universitaria di Sassari

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Moccia E, Sanna GD, Parodi G. Transient left bundle branch block and intraventricular dyssynchrony as a cause of reversible left ventricular dysfunction: The "in vivo" documentation of spontaneous electrical remodeling. Ann Noninvasive Electrocardiol. 2019 Nov;24(6):e12667. doi: 10.1111/anec.12667. Epub 2019 May 29.
• Sanna GD, De Bellis A, Zecchin M, Beccu E, Carta P, Moccia E, Canonico ME, Parodi G, Sinagra G, Merlo M. Prevalence, clinical and instrumental features of left bundle branch block-induced cardiomyopathy: the CLIMB registry. ESC Heart Fail. 2021 Dec;8(6):5589-5593. doi: 10.1002/ehf2.13568. Epub 2021 Sep 12.
• Sanna GD, Merlo M, Moccia E, Fabris E, Masia SL, Finocchiaro G, Parodi G, Sinagra G. Left bundle branch block-induced cardiomyopathy: a diagnostic proposal for a poorly explored pathological entity. Int J Cardiol. 2020 Jan 15;299:199-205. doi: 10.1016/j.ijcard.2019.06.008. Epub 2019 Jun 4. Review.

• Responsible Party: Giuseppe Damiano Sanna, MD PhD, Azienda Ospedaliero Universitaria di Sassari
• ClinicalTrials.gov Identifier: NCT05283603
• Other Study ID Numbers: PG/2019/8862
• First Posted: Mar 17, 2022
• Last Update Posted: Mar 17, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bundle-Branch Block; Heart Block

Study Results

No Results Posted as of Mar 17, 2022