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Recruiting NCT05283603

Clinical Observational Registry of Patients With Left Bundle Branch Block

Observational Left Bundle Branch Block (LBBB) on ECG

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECG, Echocardiogram, Magnetic resonance.
Who it may be relevant to
Registry conditions: Left Bundle Branch Block (LBBB) on ECG. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra

Overview

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.

Interventions

  • Diagnostic test ECG, Echocardiogram, Magnetic resonance
    Clinical and instrumental follow-up

Primary outcome measures

  • Left ventricular dysfunction [Time frame: 20 years]
Secondary outcome measures (1)
  • Adverse cardiovascular events (e.g., heart failure) [Time frame: 20 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

Italy · 1 center
  • Cardiology, AOU Sassari — Sassari

Publications

  • 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. PMID 34510787
  • 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. PMID 31186131
  • 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. PMID 31141243

Identifiers

NCT: NCT05283603 · PG/2019/8862

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗