ClinicalTrials.gg
RecruitingNCT03096678Updated Apr 11, 2017

Prognosis of Patients With Compete Left Bundle Branch Block

An observational study in Bundle-Branch Block, Left, Cardiac Failure and ICD/Pacemaker Implantation, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-11.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2020, 5 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2010; still recruiting 16 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

The effect of cardiac resynchronization therapy (CRT) for heart failure patients was heterogeneous. Candidate selection was important before intervention. The underlying mechanical dyssynchrony of left ventricular bundle branch block was insufficiently descripted. Earlier study of investigators found novel imaging methods such as cardiovascular magnetic resonance imaging including T1 Mapping and feature tracking imaging can provide more detailed information about regional and global LV function in patients. While the role of new cardiac MR imaging techniques in predicting CRT responses, especially in LBBB patients, is still insufficient. Z Chen et al used T1 mapping technique to quantitatively assess the diffuse fibrosis burden of myocardial in heart failure patients. But they found focal fibrosis burden, not diffuse burden, is associated with a poor response to CRT. Other cardiac MR imaging parameters also showed potential predictors of CRT, such as 16 segment time-to-maximum radial wall thickness , scar locations and RV septal lead placement.In this study cardiovascular magnetic resonance imaging (including T1 Mapping combined with feature tracking imaging ) will be applied to follow up LV function in LBBB patients (with or without intervention) in 10 years to find out prognostic predictors and time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.

02

Conditions studied

  • Bundle-Branch Block, Left
  • Cardiac Failure
  • ICD/Pacemaker Implantation
  • Cardiovascular Magnetic Resonance Imaging

Keywords

  • Left Bundle Branch Block
  • Regional/Globle cardiac function
  • Mechanical asynchrony
  • Cardiovascular Magnetic Resonance
  • Outcome
  • Cardiovascular events
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 500 is above the median of 162 across 33 observational studies indexed under Bundle-Branch Block.

Browse Bundle-Branch Block studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 147 studies on the registry; 51 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

subjects with complete left bundle branch block

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

  • 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 functional class I, II or III.

Exclusion criteria

Exclusion Criteria:

  • No
  • 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
Terms in these criteria, in plain language(2)

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • Diagnostic testCardiac Magnetic Resonance Imaging

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

06

What researchers measure

Primary outcomes

  1. All-cause death

    Time frame: 10 years

  2. Cardiovascular death

    Time frame: 10 years

  3. Heart Transplantation

    Time frame: 10 years

Secondary outcomes

  1. ICD Implantation

    Time frame: 10 years

  2. Pacemaker Implantation

    Time frame: 10 years

  3. Myocardial Infarction

    Time frame: 10 years

  4. Hospitalization due to heart failure

    Time frame: 10 years

  5. Stroke

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 2950157 ↗
  • 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. PubMed 12729851 ↗
  • 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. PubMed 19578165 ↗
  • 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. PubMed 23735442 ↗
  • 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. PubMed 24387626 ↗
  • 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. PubMed 25348690 ↗
  • 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. PubMed 26248989 ↗
  • 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. PubMed 27013249 ↗
  • 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. PubMed 26833321 ↗
  • 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. Erratum In: JACC Cardiovasc Imaging. 2017 Mar;10(3):384. doi: 10.1016/j.jcmg.2017.01.006. PubMed 26762873 ↗
  • 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. PubMed 26762877 ↗
  • 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. PubMed 26990922 ↗
  • 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. PubMed 27614941 ↗
  • 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. PubMed 28233534 ↗
  • 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. PubMed 28224924 ↗
  • 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. PubMed 28258731 ↗
  • 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. PubMed 23850250 ↗
  • 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. PubMed 23333530 ↗
  • 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. PubMed 26884612 ↗

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 Apr 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03096678
Responsible party
Minjie Lu (Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Mar 30, 2017
Start date
Jan 1, 2010
Primary completion
Dec 31, 2020 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 11, 2017

Study contacts

Minjie Lu, MD,PhD
Contact
lumjcn@hotmail.com
+861088398175
Jinhui Li, MD
Contact
ljhasuka@163.com
+861088398158
Minjie Lu, MD,PhD
study chair · 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

Oversight

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

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