Clinical Observational Registry of Patients With Left Bundle Branch Block

NCT ID: NCT05283603

Last Updated: 2022-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-31

Study Completion Date

2029-07-31

Brief Summary

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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

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Conditions

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Left Bundle Branch Block (LBBB) on ECG

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ECG, Echocardiogram, Magnetic resonance

Clinical and instrumental follow-up

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero Universitaria di Sassari

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Damiano Sanna

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiology, AOU Sassari

Sassari, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe D Sanna, MD PhD

Role: CONTACT

+39 0792061561

Giuseppe D Sanna, MD PhD

Role: CONTACT

+39 0792061561

Facility Contacts

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Giuseppe D Sanna, MD PhD

Role: primary

0039 2061561

References

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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.

Reference Type BACKGROUND
PMID: 34510787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31186131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31141243 (View on PubMed)

Other Identifiers

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PG/2019/8862

Identifier Type: -

Identifier Source: org_study_id

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