Prognosis of Patients With Compete Left Bundle Branch Block

Cardiac Failure Clinical Trial

Official title:

Morphological and Functional Changes, Risk Stratification and Prognosis of Patients With Compete Left Bundle Branch Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096678
• Other study ID #: LBBB001
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2017
• Last updated: April 9, 2017
• Start date: January 1, 2010
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2017
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Minjie Lu, MD,PhD
• Phone: +861088398175
• Email: lumjcn[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	Beijing Anzhen Hospital, China-Japan Friendship Hospital, National Heart, Lung, and Blood Institute (NHLBI), Peking Union Medical College Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

References & Publications (19)

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. Review. — View Citation

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. Review. — View Citation

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. Epub 2016 Mar 24. — View Citation

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. — View Citation

Cerit L. Prediction of Readmission for Congestive Heart Failure With or Without Left Bundle Branch Block. Am J Cardiol. 2017 Feb 2. pii: S0002-9149(17)30075-9. doi: 10.1016/j.amjcard.2017.01.010. [Epub ahead of print] — View Citation

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. — View Citation

Flowers NC. Left bundle branch block: a continuously evolving concept. J Am Coll Cardiol. 1987 Mar;9(3):684-97. Review. — View Citation

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. — View Citation

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

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 Magne — View Citation

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: — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

van der Graaf AW, Bhagirath P, Scheffer MG, de Medina RR, Götte 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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death		10 years
Primary	Cardiovascular death		10 years
Primary	Heart Transplantation		10 years
Secondary	ICD Implantation		10 years
Secondary	Pacemaker Implantation		10 years
Secondary	Myocardial Infarction		10 years
Secondary	Hospitalization due to heart failure		10 years
Secondary	Stroke		10 years