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

Active, not recruiting
Conditions
Left Ventricular Hypertrophy
Heart Failure
Heart Dilation
Registration Number
NCT05726695
Lead Sponsor
University Hospital Ostrava
Brief Summary

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

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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Levels of miRNA (in pmol/L)43 months

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.

Secondary Outcome Measures
NameTimeMethod
Correlation between miRNA levels and 1-year mortality and risk of rehospitalization43 months

We will examine levels of miRNA in corelation to 1-year mortality and risk of rehospitalization acquired from Czech national registry (UZIS).

Trial Locations

Locations (1)

University Hospital Ostrava

🇨🇿

Ostrava-Poruba, Czech Republic, Czechia

University Hospital Ostrava
🇨🇿Ostrava-Poruba, Czech Republic, Czechia

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