Prognosis of Patients With Compete Left Bundle Branch Block
NCT ID: NCT03096678
Last Updated: 2017-04-11
Study Results
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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RECRUITING
500 participants
OBSERVATIONAL
2010-01-01
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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LBBB without LV dysfunction
LVEDD\>55mm or LVEF\<55%
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.
LBBB with LV dysfunction
LVEDD\<55mm and LVEF\>55%
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Beijing Anzhen Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Peking Union Medical College Hospital
OTHER
Xuanwu Hospital, Beijing
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Chinese Academy of Medical Sciences, Fuwai Hospital
OTHER
Responsible Party
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Minjie Lu
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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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LBBB001
Identifier Type: -
Identifier Source: org_study_id
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