Clinical Observational Registry of Patients With Left Bundle Branch Block
RECOrd-LBBB
Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2021
CompletedFirst Submitted
Initial submission to the registry
February 25, 2022
CompletedFirst Posted
Study publicly available on registry
March 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
ExpectedMarch 17, 2022
February 1, 2022
1.9 years
February 25, 2022
March 12, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Left ventricular dysfunction
Echocardiographic left ventricular ejection fraction - EF (%)
20 years
Secondary Outcomes (1)
Adverse cardiovascular events (e.g., heart failure)
20 years
Interventions
Clinical and instrumental follow-up
Eligibility Criteria
Patients with LBBB
You may qualify if:
- LBBB on ECG
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology, AOU Sassari
Sassari, 07100, Italy
Related Publications (3)
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: 34510787BACKGROUNDSanna 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: 31186131BACKGROUNDMoccia 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: 31141243BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 20 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
February 25, 2022
First Posted
March 17, 2022
Study Start
July 31, 2019
Primary Completion
June 10, 2021
Study Completion (Estimated)
July 31, 2029
Last Updated
March 17, 2022
Record last verified: 2022-02