NCT03096678

Brief Summary

The investigators sought to evaluate the morphological and functional changes, risk stratification and prognosis of patients of participants with compete left bundle branch block (CLBBB). The conduction of this study was largely due to the increased clinical requirement, which reflected the increased awareness among physicians of heart failure due to asynchronous cardiac function caused by CLBBB. The investigators also aim to figure out the time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

11 years

First QC Date

March 25, 2017

Last Update Submit

April 9, 2017

Conditions

Bundle-Branch Block, LeftCardiac FailureICD/Pacemaker ImplantationCardiovascular Magnetic Resonance Imaging

Keywords

Left Bundle Branch BlockRegional/Globle cardiac functionMechanical asynchronyCardiovascular Magnetic ResonanceOutcomeCardiovascular events

Outcome Measures

Primary Outcomes (3)

  • All-cause death

    10 years

  • Cardiovascular death

    10 years

  • Heart Transplantation

    10 years

Secondary Outcomes (5)

  • ICD Implantation

    10 years

  • Pacemaker Implantation

    10 years

  • Myocardial Infarction

    10 years

  • Hospitalization due to heart failure

    10 years

  • Stroke

    10 years

Study Arms (2)

LBBB without LV dysfunction

LVEDD\>55mm or LVEF\<55%

Diagnostic Test: Cardiac Magnetic Resonance Imaging

LBBB with LV dysfunction

LVEDD\<55mm and LVEF\>55%

Diagnostic Test: Cardiac Magnetic Resonance Imaging

Interventions

Cardiac Magnetic Resonance ImagingDIAGNOSTIC_TEST

Using a comprehensive MR study (Function, LGE, Tissue Characterization, Strain, T1/T2 mapping) to predict the outcome of LBBB with different cardiac function.

LBBB with LV dysfunctionLBBB without LV dysfunction

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

subjects with complete left bundle branch block

You may qualify if:

  • Subject is 18 years or older and able and willing to consent.
  • The patient should present a complete left bundle branch block (LBBB) with QRS duration of \>120ms
  • The patients should be in NYHA functional class I, II or III.

You may not qualify if:

  • No informed consent
  • Permanent atrial fibrillation, flutter or tachycardia (\>100 bpm).
  • Right bundle branch block
  • Recent myocardial infarction, within 40 days prior to enrolment.
  • Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days.
  • Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year.
  • Severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period).
  • Complex and uncorrected congenital heart disease.
  • Claustrophobia or devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (19)

  • Flowers NC. Left bundle branch block: a continuously evolving concept. J Am Coll Cardiol. 1987 Mar;9(3):684-97. doi: 10.1016/s0735-1097(87)80065-7.

    PMID: 2950157BACKGROUND

  • Ansalone G, Giannantoni P, Ricci R, Trambaiolo P, Fedele F, Santini M. Biventricular pacing in heart failure: back to basics in the pathophysiology of left bundle branch block to reduce the number of nonresponders. Am J Cardiol. 2003 May 8;91(9A):55F-61F. doi: 10.1016/s0002-9149(02)03339-8.

    PMID: 12729851BACKGROUND

  • Marsan NA, Westenberg JJ, Ypenburg C, van Bommel RJ, Roes S, Delgado V, Tops LF, van der Geest RJ, Boersma E, de Roos A, Schalij MJ, Bax JJ. Magnetic resonance imaging and response to cardiac resynchronization therapy: relative merits of left ventricular dyssynchrony and scar tissue. Eur Heart J. 2009 Oct;30(19):2360-7. doi: 10.1093/eurheartj/ehp280. Epub 2009 Jul 4.

    PMID: 19578165BACKGROUND

  • Sohal M, Shetty A, Duckett S, Chen Z, Sammut E, Amraoui S, Carr-White G, Razavi R, Rinaldi CA. Noninvasive assessment of LV contraction patterns using CMR to identify responders to CRT. JACC Cardiovasc Imaging. 2013 Aug;6(8):864-73. doi: 10.1016/j.jcmg.2012.11.019. Epub 2013 Jun 2.

    PMID: 23735442BACKGROUND

  • Kellman P, Hansen MS. T1-mapping in the heart: accuracy and precision. J Cardiovasc Magn Reson. 2014 Jan 4;16(1):2. doi: 10.1186/1532-429X-16-2.

    PMID: 24387626BACKGROUND

  • Ambale-Venkatesh B, Lima JA. Cardiac MRI: a central prognostic tool in myocardial fibrosis. Nat Rev Cardiol. 2015 Jan;12(1):18-29. doi: 10.1038/nrcardio.2014.159. Epub 2014 Oct 28.

    PMID: 25348690BACKGROUND

  • Risum N, Tayal B, Hansen TF, Bruun NE, Jensen MT, Lauridsen TK, Saba S, Kisslo J, Gorcsan J 3rd, Sogaard P. Identification of Typical Left Bundle Branch Block Contraction by Strain Echocardiography Is Additive to Electrocardiography in Prediction of Long-Term Outcome After Cardiac Resynchronization Therapy. J Am Coll Cardiol. 2015 Aug 11;66(6):631-41. doi: 10.1016/j.jacc.2015.06.020.

    PMID: 26248989BACKGROUND

  • Aurich M, Keller M, Greiner S, Steen H, Aus dem Siepen F, Riffel J, Katus HA, Buss SJ, Mereles D. Left ventricular mechanics assessed by two-dimensional echocardiography and cardiac magnetic resonance imaging: comparison of high-resolution speckle tracking and feature tracking. Eur Heart J Cardiovasc Imaging. 2016 Dec;17(12):1370-1378. doi: 10.1093/ehjci/jew042. Epub 2016 Mar 24.

    PMID: 27013249BACKGROUND

  • Bogarapu S, Puchalski MD, Everitt MD, Williams RV, Weng HY, Menon SC. Novel Cardiac Magnetic Resonance Feature Tracking (CMR-FT) Analysis for Detection of Myocardial Fibrosis in Pediatric Hypertrophic Cardiomyopathy. Pediatr Cardiol. 2016 Apr;37(4):663-73. doi: 10.1007/s00246-015-1329-8. Epub 2016 Jan 30.

    PMID: 26833321BACKGROUND

  • Puntmann VO, Carr-White G, Jabbour A, Yu CY, Gebker R, Kelle S, Hinojar R, Doltra A, Varma N, Child N, Rogers T, Suna G, Arroyo Ucar E, Goodman B, Khan S, Dabir D, Herrmann E, Zeiher AM, Nagel E; International T1 Multicentre CMR Outcome Study. T1-Mapping and Outcome in Nonischemic Cardiomyopathy: All-Cause Mortality and Heart Failure. JACC Cardiovasc Imaging. 2016 Jan;9(1):40-50. doi: 10.1016/j.jcmg.2015.12.001.

    PMID: 26762873BACKGROUND

  • Taylor AJ, Salerno M, Dharmakumar R, Jerosch-Herold M. T1 Mapping: Basic Techniques and Clinical Applications. JACC Cardiovasc Imaging. 2016 Jan;9(1):67-81. doi: 10.1016/j.jcmg.2015.11.005.

    PMID: 26762877BACKGROUND

  • van der Graaf AW, Bhagirath P, Scheffer MG, de Medina RR, Gotte MJ. MR feature tracking in patients with MRI-conditional pacing systems: The impact of pacing. J Magn Reson Imaging. 2016 Oct;44(4):964-71. doi: 10.1002/jmri.25229. Epub 2016 Mar 17.

    PMID: 26990922BACKGROUND

  • Witt CM, Wu G, Yang D, Hodge DO, Roger VL, Cha YM. Outcomes With Left Bundle Branch Block and Mildly to Moderately Reduced Left Ventricular Function. JACC Heart Fail. 2016 Nov;4(11):897-903. doi: 10.1016/j.jchf.2016.07.002. Epub 2016 Sep 7.

    PMID: 27614941BACKGROUND

  • Cerit L. Prediction of Readmission for Congestive Heart Failure With or Without Left Bundle Branch Block. Am J Cardiol. 2017 Jul 15;120(2):337. doi: 10.1016/j.amjcard.2017.01.010. Epub 2017 Feb 2. No abstract available.

    PMID: 28233534BACKGROUND

  • Erne P, Iglesias JF, Urban P, Eberli FR, Rickli H, Simon R, Fischer TA, Radovanovic D. Left bundle-branch block in patients with acute myocardial infarction: Presentation, treatment, and trends in outcome from 1997 to 2016 in routine clinical practice. Am Heart J. 2017 Feb;184:106-113. doi: 10.1016/j.ahj.2016.11.003. Epub 2016 Nov 10.

    PMID: 28224924BACKGROUND

  • Kawji MM, Glancy DL. Hypotension and Left Bundle Branch Block. Am J Cardiol. 2017 Apr 15;119(8):1292-1293. doi: 10.1016/j.amjcard.2016.11.070. Epub 2017 Jan 25.

    PMID: 28258731BACKGROUND

  • Lu M, Zhao S, Jiang S, Yin G, Wang C, Zhang Y, Liu Q, Cheng H, Ma N, Zhao T, Chen X, Huang J, Zou Y, Song L, He Z, An J, Renate J, Xue H, Shah S. Fat deposition in dilated cardiomyopathy assessed by CMR. JACC Cardiovasc Imaging. 2013 Aug;6(8):889-98. doi: 10.1016/j.jcmg.2013.04.010. Epub 2013 Jul 10.

    PMID: 23850250RESULT

  • Lu M, Zhao S, Yin G, Jiang S, Zhao T, Chen X, Tian L, Zhang Y, Wei Y, Liu Q, He Z, Xue H, An J, Shah S. T1 mapping for detection of left ventricular myocardial fibrosis in hypertrophic cardiomyopathy: a preliminary study. Eur J Radiol. 2013 May;82(5):e225-31. doi: 10.1016/j.ejrad.2012.12.014. Epub 2013 Jan 17.

    PMID: 23333530RESULT

  • Lu M, Du H, Gao Z, Song L, Cheng H, Zhang Y, Yin G, Chen X, Ling J, Jiang Y, Wang H, Li J, Huang J, He Z, Zhao S. Predictors of Outcome After Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy: An Echocardiography and Cardiovascular Magnetic Resonance Imaging Study. Circ Cardiovasc Interv. 2016 Mar;9(3):e002675. doi: 10.1161/CIRCINTERVENTIONS.115.002675.

    PMID: 26884612RESULT

MeSH Terms

Conditions

Bundle-Branch BlockHeart Failure

Condition Hierarchy (Ancestors)

Heart BlockArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Minjie Lu, MD,PhD

    Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical, Sciences and Peking Union Medical College

    STUDY CHAIR

Central Study Contacts

Minjie Lu, MD,PhD

CONTACT

+861088398175lumjcn@hotmail.com

Jinhui Li, MD

CONTACT

+861088398158ljhasuka@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2017

First Posted

March 30, 2017

Study Start

January 1, 2010

Primary Completion

December 31, 2020

Study Completion

December 31, 2025

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

CN(1)