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RecruitingNCT05283603RECOrd-LBBBUpdated Mar 17, 2022

Clinical Observational Registry of Patients With Left Bundle Branch Block

An observational study in Left Bundle Branch Block (LBBB) on ECG, sponsored by Azienda Ospedaliero Universitaria di Sassari. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-17.

Sponsored by Azienda Ospedaliero Universitaria di Sassari · Observational

From the registry’s dates

  • Started Jul 2019; still recruiting 7 years 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Left Bundle Branch Block (LBBB) on ECG

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03

In context

Bundle-Branch Block

94 studies on the registry are indexed under Bundle-Branch Block; 30 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 162 across 33 observational studies indexed under Bundle-Branch Block.

Browse Bundle-Branch Block studies →

Lead sponsor

Azienda Ospedaliero Universitaria di Sassari is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with LBBB

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • LBBB on

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
20 Years
Patient registry
Yes

Interventions

  • Diagnostic testECG, Echocardiogram, Magnetic resonance

    Clinical and instrumental follow-up

06

What researchers measure

Primary outcomes

  1. Left ventricular dysfunction

    Echocardiographic left ventricular ejection fraction - EF (%)

    Time frame: 20 years

Secondary outcomes

  1. Adverse cardiovascular events (e.g., heart failure)

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

    Time frame: 20 years

07

Study locations

1 of 1 sites recruiting
  • Cardiology, AOU Sassari
    Sassari, 07100, Italy
    Recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 31141243 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05283603
Lead sponsor
Azienda Ospedaliero Universitaria di Sassari
Responsible party
Giuseppe Damiano Sanna (MD PhD, Azienda Ospedaliero Universitaria di Sassari) — Principal investigator
First posted
Mar 17, 2022
Start date
Jul 31, 2019
Primary completion
Jun 10, 2021
Completion
Jul 31, 2029 (estimated)
Last update
Mar 17, 2022

Study contacts

Giuseppe D Sanna, MD PhD
Contact
giuseppe.sanna@aousassari.it
+39 0792061561
Giuseppe D Sanna, MD PhD
Contact
+39 0792061561

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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