The Use of Blood Biochemical Markers for Diagnostics of Heart Muscle Diseases

Study Overview
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Brief Summary
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The aim of the study is to determine the analytical characteristics of the microRNA enzymatic immunoassay (miREIA) method and to determine various relations among miRNA biomarkers and heart failure (HF) with reduced ejection fraction(HFrEF). The investigators assume that there are correlations between levels of selected miRNA and HFrEF. These correlations provide information to formulate pathophysiological conclusions, which will significantly contribute to early diagnostics and also the treatment of this disease.

Detailed Description
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Heart failure presents a significant diagnostic and treatment problem. The mortality in the Czech Republic related to this condition is high. The current treatment strategy consists of the administration of medication to patients, in order to attenuate the clinical manifestations of the disease and to influence the overall survival of patients suffering from this condition. Another treatment option is a mini-invasive procedure, with implantation of a pacemaker with biventricular stimulation, or transplantation of the heart. Despite these treatment options, the mortality of patients due to heart failure remains high, and new approaches are being studied for the diagnostics and treatment of heart failure. Factors that may play an important role in earlier diagnostics are miRNA. These molecules are located in the circulating blood. They are being described as suitable prognostic markers of heart failure, which may contribute to earlier diagnostics and bring a better understanding of processes going on in the human body. In the study, the authors will take blood samples in order to analyze the presence of miRNA. These levels of miRNA will be compared with heart ultrasound parameters of HF patients and healthy control subjects.

Official Title
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The Use of miRNA Detection for Diagnostics of Cardiovascular Diseases

Conditions
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Heart Failure, Heart Dilation, Left Ventricular Hypertrophy

Intervention / Treatment
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* Diagnostic Test: microRNA test
* Diagnostic Test: Heart ultrasound examination


Participation Criteria
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Eligibility Criteria
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Inclusion criteria (patient group): left ventricle ejection fraction (EF LV) equal or less than 40% age between 18-80 years Inclusion criteria (control group): normal EF LV (left ventricular ejection fraction) no structural cardiac abnormalities age between 18-80 years. Exclusion criteria: recent myocardial infarction recent percutaneous coronary intervention (PCI) recent decompensation of chronic heart failure chronic kidney disease with need for haemodialysis creatin level over 450 umol/l signs of acute or chronic inflammation with CRP (C-reactive protein) over 20 mg/l patient with a known tumour history of cardiovascular disease diabetes mellitus severe liver and kidney disease BNP (brain natriuretic peptide) > 250 pg/ml or NTproBNP > 500 pg/ml for males and 750 pg/ml for females signs of acute or chronic inflammation with CRP over 20 mg/l

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Heart failure with reduced ejection fraction.<br>Patients indicated for biochemical analysis due to a suspected heart disease, with HFrEF diagnosed on echocardiography with left-ventricular ejection fraction lower than 35%. Diagnostic Test: MicroRNA test. Laboratory analysis for the detection of microRNA in blood samples. Diagnostic Test: Heart ultrasound examination. Heart ultrasound examination will be performed as a standard cardiology examination. | Diagnostic Test: microRNA test<br>* Laboratory analysis for the detection of microRNA in blood samples.<br>Diagnostic Test: Heart ultrasound examination<br>* Heart ultrasound examination will be performed as a standard cardiology examination.<br>|
| Control group<br>Patients with no known heart disease (hypertrophy or dilatation), which has been confirmed on echocardiography. Diagnostic Test: microRNA test. Laboratory analysis for the detection of microRNA in blood samples. Diagnostic Test: Heart ultrasound examination. Heart ultrasound examination will be performed as a standard cardiology examination. | Diagnostic Test: microRNA test<br>* Laboratory analysis for the detection of microRNA in blood samples.<br>Diagnostic Test: Heart ultrasound examination<br>* Heart ultrasound examination will be performed as a standard cardiology examination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of miRNA (in pmol/L) | Full blood samples will be taken in both groups after period of clinically stable state and analyzed for levels of miRNA(hsa-miR-21-5p; hsa-miR-23a-3p; hsa-miR-142-5p; hsa-miR-126-3p) with biochemical microRNA enzymatic immunoassay. Measured levels of listed four miRNAs will be provided pmol/L. These levels will be statistically analyzed and compared between patient and control group. | 43 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between miRNA levels and 1-year mortality and risk of rehospitalization | We will examine levels of miRNA in corelation to 1-year mortality and risk of rehospitalization acquired from Czech national registry (UZIS). | 43 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microRNA, immunomethods, heart failure biomarkers