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

University Hospital Ostrava

Status: Active, not recruiting

Conditions: Heart Dilation; Left Ventricular Hypertrophy; Heart Failure

Treatments: Diagnostic Test: microRNA test; Diagnostic Test: Heart ultrasound examination

Study type: Observational

Funder types: Other

Identifiers

NCT05726695

miRNA-RVO-FNOs/2018-05KVO

RVO-FNOs/2018-05KVO (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

200 participants in 2 patient groups

Heart failure with reduced ejection fraction.

Description:

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.

Treatment:

Diagnostic Test: microRNA test

Diagnostic Test: Heart ultrasound examination

Control group

Description:

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.

Treatment:

Diagnostic Test: microRNA test

Diagnostic Test: Heart ultrasound examination