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Trial record 2 of 42 for:    Heart Block | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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

Tracking Information
First Submitted Date March 25, 2017
First Posted Date March 30, 2017
Last Update Posted Date April 11, 2017
Actual Study Start Date January 1, 2010
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2017)
  • All-cause death [ Time Frame: 10 years ]
  • Cardiovascular death [ Time Frame: 10 years ]
  • Heart Transplantation [ Time Frame: 10 years ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03096678 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 25, 2017)
  • ICD Implantation [ Time Frame: 10 years ]
  • Pacemaker Implantation [ Time Frame: 10 years ]
  • Myocardial Infarction [ Time Frame: 10 years ]
  • Hospitalization due to heart failure [ Time Frame: 10 years ]
  • Stroke [ Time Frame: 10 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognosis of Patients With Compete Left Bundle Branch Block
Official Title Morphological and Functional Changes, Risk Stratification and Prognosis of Patients With Compete Left Bundle Branch Block
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.

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]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population subjects with complete left bundle branch block
Condition
  • Bundle-Branch Block, Left
  • Cardiac Failure
  • ICD/Pacemaker Implantation
  • Cardiovascular Magnetic Resonance Imaging
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.
Study Groups/Cohorts
  • LBBB without LV dysfunction
    LVEDD>55mm or LVEF<55%
    Intervention: Diagnostic Test: Cardiac Magnetic Resonance Imaging
  • LBBB with LV dysfunction
    LVEDD<55mm and LVEF>55%
    Intervention: Diagnostic Test: Cardiac Magnetic Resonance Imaging
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 25, 2017)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2025
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Minjie Lu, MD,PhD +861088398175 lumjcn@hotmail.com
Contact: Jinhui Li, MD +861088398158 ljhasuka@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03096678
Other Study ID Numbers LBBB001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sponsor Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborators
  • 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
PRS Account Chinese Academy of Medical Sciences, Fuwai Hospital
Verification Date April 2017