Clinical Trial: Metabolomics Study of Cardiomyopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Metabolomic Study of Patients With Cardiomyopathy in China

Brief Summary: This study aims to 1)characterize the differentially expressed metabolites between cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up of a cohort and 3)to determine whether differentially expressed may affect the pathological process of cardiomyopathies . Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of blood plasma.

Detailed Summary: The aim of this study is to analyze metabolomic profile of patients with cardiomyopathy in order to identify biochemical markers with risk stratification and prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors，clinical lab data and previous cardiovascular disease will be recorded. Follow up will be at 3 months,6 months,9 months,1 year and 3 years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients with cardiomyopathy are taken when they enrolled. Serum samples will be analyzed by Liquid Chromatograph Mass Spectrometer/Mass Spectrometer.
Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases

Current Primary Outcome: Result of echocardiography [ Time Frame: three year ]

The whole results of echocardiography report will be recorded. The indicates whi ch can reflect cardiac function including Left ventricular ejection fraction, left ventricular end diastolic diameter, E/A ratio of bicuspid valve will be used to calculate the association with metabolites.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cardiovascular death [ Time Frame: One year/Three year ]
    The data is collected during follow-up visit at 1/3 years after discharge
  • Re-hospitalization [ Time Frame: One year/Three year ]
    patients are hospitalized due to heart failure with decreasing left ventricular ejection fraction (LVEF) or worsen symptoms. The data is collected during follow-up visit at 1/3 years after discharge
  • Heart transplantation [ Time Frame: One year/Three year ]
    patients are hospitalized due to heart failure.The data is collected during follow-up visit at 1/3 years after discharge
  • malignant arrythmia [ Time Frame: One year/Three year ]
    Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.
  • Worsening heart failure [ Time Frame: These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting ]
    Worsen heart failure is defined as decreased ejection fraction(left ventricular ejection fraction decreased over 10%), left ventricular ejection fraction <45% and enlarged heart size measured by echocardiography and changing level of New York Heart Association (NYHA) Functional Classification.And patients who undergo left ventricular assist device (LVAD) will also be included.The data is collected during follow-up visit at 3/6/9/12/36 months after enrollment.
  • Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample [ Time Frame: The data is collected from lab in an average of 3 month after the sample recruiting ]
    The results of metabolomics will be measured by mass spectrometry, including lipids, sugars and amino acids. All of metabolites will be quantitative(unit:mol/L). Identification of molecules via Human Metabolites Database will be reported online.


Original Secondary Outcome:

  • Cardiovascular death [ Time Frame: One year/Three year ]
    The data is collected during follow-up visit at 1/3 years after discharge
  • Re-hospitalization [ Time Frame: One year/Three year ]
    Patitents are hospitalized due to heart failure with decreasing LVEF or worsen symptoms. The data is collected during follow-up visit at 1/3 years after discharge
  • Heart transplantation [ Time Frame: One year/Three year ]
    Patitents are hospitalized due to heart failure.The data is collected during follow-up visit at 1/3 years after discharge
  • malignant arrythmia [ Time Frame: One year/Three year ]
    Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be ICD implantation.
  • Worsening heart failure [ Time Frame: These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting ]
    Worsen heart failure is defined as decreased ejection fraction( LVEF decreased over 10%), LVEF<45% and enlarged heart size measured by echocardiography and changing level of NYHA.And patienys who undergo LVAD(left ventricular assist device) will also be included.The data is collected during follow-up visit at 3/6/9/12/36 months after enrollmemt.
  • Metabolomic profile on LC MS/MS analysis of plasma sample [ Time Frame: The data is collected from lab in an average of 3 month after the sample recruiting ]
    The results of metabolomics will be measured by mass spectrometry, including lipids, sugars and amino acids. All of metabolites will be quantitative(unit:mol/L). Identification of molecules via Human Metabolites Database will be reported online.


Information By: Beijing Institute of Heart, Lung and Blood Vessel Diseases

Dates:
Date Received: February 6, 2017
Date Started: October 2016
Date Completion: October 2020
Last Updated: March 1, 2017
Last Verified: March 2017