Metabolomic Study of All-age Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

— MAC  

Official title:

Metabolomic Study of Patients With Cardiomyopathy in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061994
• Other study ID #: BeijingIHLBVD2016023
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2017
• Last updated: May 26, 2017
• Start date: October 2016
• Est. completion date: October 2020

Study information

• Verified date: March 2017
• Source: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Contact: Jie Du, PhD
• Email: jiedubj[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: October 2020
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.

2. Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures

Exclusion Criteria:

1. Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)

2. History of rheumatic fever

3. Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)

4. HIV infection or born to an HIV positive mother

5. Kawasaki disease

6. Immunologic disease

7. Uremia, active or chronic

8. Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia

10.Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded) 11.Malignancy 12.Pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension) 13.Ischemic coronary vascular disease 14.Association with drugs (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy

Related Conditions & MeSH terms

• Arrhythmogenic Right Ventricular Cardiomyopathy
• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• Dilated Cardiomyopathy
• Hypertrophic Cardiomyopathy
• Hypertrophy
• Left Ventricular Non-compaction
• Restrictive Cardiomyopathy

Locations

Country	Name	City	State
China	Beijing Institute of heart, lung and blood vessel diseases	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result of echocardiography	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.	three year
Secondary	Cardiovascular death	The data is collected during follow-up visit at 1/3 years after discharge	One year/Three year
Secondary	Re-hospitalization	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	One year/Three year
Secondary	Heart transplantation	patients are hospitalized due to heart failure.The data is collected during follow-up visit at 1/3 years after discharge	One year/Three year
Secondary	malignant arrythmia	Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.	One year/Three year
Secondary	Worsening heart failure	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.	These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting
Secondary	Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample	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.	The data is collected from lab in an average of 3 month after the sample recruiting