Clinical Observational Registry of Patients With Left Bun... | NCT05283603

Studies
Clinical Observational Registry of Patients With Left Bundle Branch Block

NCT05283603

Sponsor

Azienda Ospedaliero Universitaria di Sassari

Status

Recruiting

Last Update Posted

Mar 17, 2022Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Left Bundle Branch Block (LBBB) on ECG

Interventions

ECG, Echocardiogram, Magnetic resonance

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 31, 2019Actual

Primary Completion Date

Jun 10, 2021Actual

Completion Date

Jul 31, 2029Estimated

First Submitted Date

Feb 25, 2022

First Submission Date that Met QC Criteria

Mar 12, 2022

First Posted Date

Mar 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2022

Last Update Posted Date

Mar 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Damiano Sanna, MD PhD, Azienda Ospedaliero Universitaria di SassariPrincipal Investigator

Lead Sponsor

Azienda Ospedaliero Universitaria di SassariOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECG, Echocardiogram, Magnetic resonance	Diagnostic Test	Clinical and instrumental follow-up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular dysfunction	Echocardiographic left ventricular ejection fraction - EF (%)	20 years

Secondary Outcomes

Measure	Description	Time Frame
Adverse cardiovascular events (e.g., heart failure)	Heart failure (incidence and prevalence) Hospitalizations due to heart failure MACE	20 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with LBBB

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giuseppe D Sanna, MD PhD	Contact	+39 0792061561		giuseppe.sanna@aousassari.it
Giuseppe D Sanna, MD PhD	Contact	+39 0792061561

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology, AOU Sassari	Recruiting	Sassari		07100	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34510787	Background	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.
31186131	Background

ID	Term
D006327	Heart Block
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D004562	Electrocardiography
D004452	Echocardiography
D008279	Magnetic Resonance Imaging

ID	Term
D006334	Heart Function Tests
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis