Clinical trial NCT03061994: Metabolomic Study of All-age Cardiomyopathy
Official title: Metabolomic Study of Patients With Cardiomyopathy in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dilated Cardiomyopathy
Hypertrophic Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathy
Left Ventricular Non-compaction
Restrictive Cardiomyopathy
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A diagnosis of cardiomyopaty is adjudicated by three cardiologists,according to current guidelines when there was clinical evidence of cardiomyopathy together with clinical symptoms of heart failure or echocardiography or imaging evidence.

age- and gender- mathced healthy controls are also recuitted in the hospital.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Result of echocardiography
timeFrame: three year
Secondary outcomes:
measure: Cardiovascular death
timeFrame: One year/Three year
measure: Re-hospitalization
timeFrame: One year/Three year
measure: Heart transplantation
timeFrame: One year/Three year
measure: malignant arrythmia
timeFrame: One year/Three year
measure: Worsening heart failure
timeFrame: These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting
measure: Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample
timeFrame: The data is collected from lab in an average of 3 month after the sample recruiting
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of heart, lung and blood vessel diseases
state: Beijing
Study officials:
affiliation: Beijing anzhen hospital affiliated to capital medical university
name: Yulin Li, PhD
role: STUDY_DIRECTOR
affiliation: Beijing anzhen hospital affiliated to capital medical university
name: Yongqiang Lai, MD
role: STUDY_DIRECTOR
References: