Left Bundle Branch Block (LBBB) on ECGRECOrd-LBBBNCT05283603
Clinical Observational Registry of Patients With Left Bundle Branch Block
An observational study of Left Bundle Branch Block (LBBB) on ECG, run by Azienda Ospedaliero Universitaria di Sassari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Bundle Branch Block (LBBB) on ECG
- What is being tested?
- ECG, Echocardiogram, Magnetic resonance
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2019to 31 Jul 2029
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with LBBB
Who may be able to join
- LBBB on ECG
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Giuseppe D Sanna, MD PhD contact
Italy1 site, 1 recruiting
- Recruiting
Cardiology, AOU Sassari
Sassari, 07100
Giuseppe D Sanna, MD PhD, 0039 2061561, giuseppe.sanna@aousassari.it
About this study
Official title: Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra
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
- To investigate the clinical, ECG, imaging-derived features in a large cohort of patients affected by LBBB on ECG.
- To identify predictors of LBBB-induced LV systolic dysfunction and predictors of outcome in this population.
- To derive data which may have an impact on therapeutic management.
- Conditions
- Left Bundle Branch Block (LBBB) on ECG
- Being tested
- ECG, Echocardiogram, Magnetic resonance
- Medical subject headings
- Bundle-Branch Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG, Echocardiogram, Magnetic resonanceDiagnostic test
Clinical and instrumental follow-up
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular dysfunction
Echocardiographic left ventricular ejection fraction - EF (%)
Measured: 20 years
Secondary outcomes (1)
Adverse cardiovascular events (e.g., heart failure)
Heart failure (incidence and prevalence) Hospitalizations due to heart failure MACE
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start31 Jul 2019
- Primary completion10 Jun 2021
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Left Bundle Branch Block (LBBB) on ECGStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Damiano Sanna, Azienda Ospedaliero Universitaria di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283603
- Sponsor's protocol ID
- PG/2019/8862
- Acronym
- RECOrd-LBBB
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 34510787Sanna 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 31186131Moccia 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra
- ClinicalTrials.gov ID
- NCT05283603
- Acronym / sponsor ID
- RECOrd-LBBB / PG/2019/8862
- Conditions
- Left Bundle Branch Block (LBBB) on ECG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria di SassariUniversity, hospital or other
- Study start
- 31 Jul 2019 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To investigate the clinical, ECG, imaging-derived features in a large cohort of patients affected by LBBB on ECG.
- To identify predictors of LBBB-induced LV systolic dysfunction and predictors of outcome in this population.
- To derive data which may have an impact on therapeutic management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with LBBB
Key inclusion criteria (1 listed)
- LBBB on ECG
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG, Echocardiogram, Magnetic resonanceClinical and instrumental follow-up | Diagnostic test | – |
Primary outcome
Left ventricular dysfunction
Time frame: 20 years
Echocardiographic left ventricular ejection fraction - EF (%)
1 secondary outcome
Adverse cardiovascular events (e.g., heart failure)
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 34510787Sanna 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.
- Background: PubMed 31186131Sanna 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.
- Background: PubMed 31141243Moccia 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giuseppe D Sanna, MD PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Bundle Branch Block (LBBB) on ECG, run by Azienda Ospedaliero Universitaria di Sassari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe D Sanna, MD PhD (+39 0792061561, giuseppe.sanna@aousassari.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular dysfunction (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05283603, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.