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| ID | Type | Description | Link |
|---|---|---|---|
| RVO-FNOs/2018-05KVO | Other Grant/Funding Number | University Hospital Ostrava |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart failure with reduced ejection fraction. | 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. |
| |
| Control group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microRNA test | Diagnostic Test | Laboratory analysis for the detection of microRNA in blood samples. |
|
| 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 |
| 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 |
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Inclusion criteria (patient group):
Inclusion criteria (control group):
Exclusion criteria:
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Patients with known stable heart failure hospitalized or followed at the outpatient clinic at the University Hospital Ostrava, Department of Cardiovascular Diseases.
The control group consists of healthy individuals, who had volunteered for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Lukáš Evin, MD,Ph.D. | University Hospital Ostrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava-Poruba | Czech Republic | 708 52 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27754357 | Background | Catalanotto C, Cogoni C, Zardo G. MicroRNA in Control of Gene Expression: An Overview of Nuclear Functions. Int J Mol Sci. 2016 Oct 13;17(10):1712. doi: 10.3390/ijms17101712. | |
| 14744438 | Background | Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5. |
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The investigators do not plan to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006332 | Cardiomegaly |
| D006984 | Hypertrophy |
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Full blood samples, no DNA examination will be performed.
| Heart ultrasound examination | Diagnostic Test | Heart ultrasound examination will be performed as a standard cardiology examination. |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |