The Use of Blood Biochemical Markers for Diagnostics of Heart Muscle Diseases
- Conditions
- Left Ventricular HypertrophyHeart FailureHeart Dilation
- Interventions
- Diagnostic Test: microRNA testDiagnostic Test: Heart ultrasound examination
- 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
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Heart failure with reduced ejection fraction. microRNA test 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 microRNA test 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. Heart failure with reduced ejection fraction. Heart ultrasound examination 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 Heart ultrasound examination 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Correlation between miRNA levels and 1-year mortality and risk of rehospitalization 43 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