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Prognosis of Patients With Compete Left Bundle Branch Block

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ClinicalTrials.gov Identifier: NCT03096678
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborators:
Beijing Anzhen Hospital
China-Japan Friendship Hospital
Peking Union Medical College Hospital
Xuanwu Hospital, Beijing
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital

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.


Condition or disease Intervention/treatment
Bundle-Branch Block, Left Cardiac Failure ICD/Pacemaker Implantation Cardiovascular Magnetic Resonance Imaging Diagnostic Test: Cardiac Magnetic Resonance Imaging

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.

Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Morphological and Functional Changes, Risk Stratification and Prognosis of Patients With Compete Left Bundle Branch Block
Actual Study Start Date : January 1, 2010
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
LBBB without LV dysfunction
LVEDD>55mm or LVEF<55%
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.

LBBB with LV dysfunction
LVEDD<55mm and LVEF>55%
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.




Primary Outcome Measures :
  1. All-cause death [ Time Frame: 10 years ]
  2. Cardiovascular death [ Time Frame: 10 years ]
  3. Heart Transplantation [ Time Frame: 10 years ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
subjects with complete left bundle branch block
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096678


Contacts
Contact: Minjie Lu, MD,PhD +861088398175 lumjcn@hotmail.com
Contact: Jinhui Li, MD +861088398158 ljhasuka@163.com

Locations
China, Beijing
Fuwai Hospital Recruiting
Beijing, Beijing, China, 100037
Contact: Xiuyu Chen, PhD    +86 10 88398175    fwchenxiuyu@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Beijing Anzhen Hospital
China-Japan Friendship Hospital
Peking Union Medical College Hospital
Xuanwu Hospital, Beijing
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Study Chair: 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

Publications of Results:
Other Publications:

Responsible Party: Minjie Lu, Principal Investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03096678     History of Changes
Other Study ID Numbers: LBBB001
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital:
Left Bundle Branch Block
Regional/Globle cardiac function
Mechanical asynchrony
Cardiovascular Magnetic Resonance
Outcome
Cardiovascular events

Additional relevant MeSH terms:
Heart Failure
Bundle-Branch Block
Heart Block
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes