Prognosis of Patients With Compete Left Bundle Branch Block

NCT ID: NCT03096678

Last Updated: 2017-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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LBBB without LV dysfunction

LVEDD\>55mm or LVEF\<55%

Cardiac Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_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 dysfunction

LVEDD\<55mm and LVEF\>55%

Cardiac Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cardiac 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 NYHA functional class I, II or III.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

China-Japan Friendship Hospital

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Minjie Lu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Minjie Lu, MD,PhD

Role: 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

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Minjie Lu, MD,PhD

Role: CONTACT

+861088398175

Jinhui Li, MD

Role: CONTACT

+861088398158

Facility Contacts

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Xiuyu Chen, PhD

Role: primary

+86 10 88398175

References

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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.

Reference Type BACKGROUND
PMID: 2950157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12729851 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 23735442 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24387626 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25348690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26248989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27013249 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26833321 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26762873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26762877 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26990922 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27614941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28233534 (View on PubMed)

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.

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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.

Reference Type RESULT
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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.

Reference Type RESULT
PMID: 23333530 (View on PubMed)

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.

Reference Type RESULT
PMID: 26884612 (View on PubMed)

Other Identifiers

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LBBB001

Identifier Type: -

Identifier Source: org_study_id

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