Clinical, Structural and Mechanical Features in Patients With Left Bundle Branch Block.

NCT04328649 | Unknown

• 1 other identifier: PoliclinicoCasilino
• Study Type: observational
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clinical, structural and mechanical features in patients with left bundle branch block.

Conditions

Left Bundle-Branch Block; Electrocardiographic Pattens; Clinical Features

Outcome Measures

Primary Outcomes (6)

• Rate of ECG pattern distribution in LBBB patients

  5 years

• Rate of underlying structural heart diseases in different LBBB pattern

  5 years

• Number of participants with stress induced myocardial ischemia during Stress Magnetic resonance

  5 years

• number or participants with late gadolinium enhancement during cardiac magnetic resonance

  5 years

• number and of participants with isolated LBBB evolving to dyssynchrony-related cardiomyopathy

  5 years

• Number of participants with mechanical dyssynchrony evaluated with Echocardiography

  Strain, Strain Rate, intraventricular timing Delay between left ventricular lateral and Septal wall

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this prospective observational study we consider to enroll patients with LBBB admitted to our Cardiology Department and Ambulatory Care Unit recording different ECG patterns, risk factors, genetic, underlying heart disease, imaging parameters (Echocardiographic and Cardiac Magnetic Resonance) and treatment (either pharmacological or interventional).

You may qualify if:

• Every patient with electrocardiographic diagnosis of LBBB admitted to our Cardiology Department and Ambulatory Care Unit
• ECG standard criteria from typical, atypical and NIVCD
• Patients who have given their informed consent in writing.
• Age ≥ 18 years

You may not qualify if:

• Age \<18 years
• Patients who have not given their informed consent in writing.

Sponsors & Collaborators

• Policlinico Casilino ASL RMB: lead

Related Publications (12)

• Akhtari S, Chuang ML, Salton CJ, Berg S, Kissinger KV, Goddu B, O'Donnell CJ, Manning WJ. Effect of isolated left bundle-branch block on biventricular volumes and ejection fraction: a cardiovascular magnetic resonance assessment. J Cardiovasc Magn Reson. 2018 Sep 20;20(1):66. doi: 10.1186/s12968-018-0457-8.

  PMID: 30231875 BACKGROUND

• Strik M, Regoli F, Auricchio A, Prinzen F. Electrical and mechanical ventricular activation during left bundle branch block and resynchronization. J Cardiovasc Transl Res. 2012 Apr;5(2):117-26. doi: 10.1007/s12265-012-9351-1. Epub 2012 Feb 7.

  PMID: 22311563 BACKGROUND

• Surawicz B, Childers R, Deal BJ, Gettes LS, Bailey JJ, Gorgels A, Hancock EW, Josephson M, Kligfield P, Kors JA, Macfarlane P, Mason JW, Mirvis DM, Okin P, Pahlm O, Rautaharju PM, van Herpen G, Wagner GS, Wellens H; American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; American College of Cardiology Foundation; Heart Rhythm Society. AHA/ACCF/HRS recommendations for the standardization and interpretation of the electrocardiogram: part III: intraventricular conduction disturbances: a scientific statement from the American Heart Association Electrocardiography and Arrhythmias Committee, Council on Clinical Cardiology; the American College of Cardiology Foundation; and the Heart Rhythm Society. Endorsed by the International Society for Computerized Electrocardiology. J Am Coll Cardiol. 2009 Mar 17;53(11):976-81. doi: 10.1016/j.jacc.2008.12.013. No abstract available.

  PMID: 19281930 BACKGROUND

• European Society of Cardiology (ESC); European Heart Rhythm Association (EHRA); Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Europace. 2013 Aug;15(8):1070-118. doi: 10.1093/europace/eut206. Epub 2013 Jun 24. No abstract available.

  PMID: 23801827 BACKGROUND

• Strauss DG, Selvester RH, Wagner GS. Defining left bundle branch block in the era of cardiac resynchronization therapy. Am J Cardiol. 2011 Mar 15;107(6):927-34. doi: 10.1016/j.amjcard.2010.11.010.

  PMID: 21376930 BACKGROUND

• Padanilam BJ, Morris KE, Olson JA, Rippy JS, Walsh MN, Subramanian N, Vidal A, Prystowsky EN, Steinberg LA. The surface electrocardiogram predicts risk of heart block during right heart catheterization in patients with preexisting left bundle branch block: implications for the definition of complete left bundle branch block. J Cardiovasc Electrophysiol. 2010 Jul;21(7):781-5. doi: 10.1111/j.1540-8167.2009.01714.x. Epub 2010 Feb 1.

  PMID: 20132380 BACKGROUND

• Kisiel R, Fijorek K, Moskal P, Kukla P, Pavlinec C, Stec J, Czarnecka D, Jastrzebski M. True left bundle branch block and long-term mortality in cardiac resynchronisation therapy patients. Kardiol Pol. 2019;77(3):371-379. doi: 10.5603/KP.a2019.0032. Epub 2019 Feb 25.

  PMID: 30799545 BACKGROUND

• Eschalier R, Ploux S, Ritter P, Haissaguerre M, Ellenbogen KA, Bordachar P. Nonspecific intraventricular conduction delay: Definitions, prognosis, and implications for cardiac resynchronization therapy. Heart Rhythm. 2015 May;12(5):1071-9. doi: 10.1016/j.hrthm.2015.01.023. Epub 2015 Jan 19.

  PMID: 25614250 BACKGROUND

• Storkas HS, Hansen TF, Tahri JB, Lauridsen TK, Olsen FJ, Borgquist R, Vinther M, Lindhardt TB, Bruun NE, Sogaard P, Risum N. Left axis deviation in patients with left bundle branch block is a marker of myocardial disease associated with poor response to cardiac resynchronization therapy. J Electrocardiol. 2020 Nov-Dec;63:147-152. doi: 10.1016/j.jelectrocard.2019.04.007. Epub 2019 Apr 5.

  PMID: 31003852 BACKGROUND

• van Stipdonk AMW, Hoogland R, Ter Horst I, Kloosterman M, Vanbelle S, Crijns HJGM, Prinzen FW, Meine M, Maass AH, Vernooy K. Evaluating Electrocardiography-Based Identification of Cardiac Resynchronization Therapy Responders Beyond Current Left Bundle Branch Block Definitions. JACC Clin Electrophysiol. 2020 Feb;6(2):193-203. doi: 10.1016/j.jacep.2019.10.009. Epub 2019 Nov 27.

  PMID: 32081223 BACKGROUND

• 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.

  PMID: 31186131 BACKGROUND

• Strauss DG, Selvester RH. The QRS complex--a biomarker that "images" the heart: QRS scores to quantify myocardial scar in the presence of normal and abnormal ventricular conduction. J Electrocardiol. 2009 Jan-Feb;42(1):85-96. doi: 10.1016/j.jelectrocard.2008.07.011. Epub 2008 Sep 13. No abstract available.

  PMID: 18790501 BACKGROUND

MeSH Terms

Conditions

Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Leonardo Calò, Professor

CONTACT

0623188406; leonardo.calo@gmail.com

Leonardo Calò, Professor

CONTACT

0623188406

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, FESC

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 31, 2020
• Study Start: May 15, 2020
• Primary Completion: April 15, 2022
• Study Completion: April 15, 2025
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share