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

NCT05726695 | Unknown

• 2 other identifiers: miRNA-RVO-FNOs/2018-05KVORVO-FNOs/2018-05KVO
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Heart Dilation; Left Ventricular Hypertrophy

Keywords

microRNA; immunomethods; heart failure biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between miRNA levels and 1-year mortality and risk of rehospitalization

  43 months

Study Arms (2)

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.

Diagnostic Test: microRNA test; Diagnostic Test: Heart ultrasound 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.

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

Interventions

microRNA test DIAGNOSTIC_TEST

Laboratory analysis for the detection of microRNA in blood samples.

Control group; Heart failure with reduced ejection fraction.

Heart ultrasound examination DIAGNOSTIC_TEST

Heart ultrasound examination will be performed as a standard cardiology examination.

Control group; Heart failure with reduced ejection fraction.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• left ventricle ejection fraction (EF LV) equal or less than 40%
• age between 18-80 years
• normal EF LV (left ventricular ejection fraction)
• no structural cardiac abnormalities
• age between 18-80 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, 708 52, Czechia

Location

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Full blood samples, no DNA examination will be performed.

MeSH Terms

Conditions

Heart Failure; Hypertrophy, Left Ventricular

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Lukáš Evin, MD,Ph.D.

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: February 14, 2023
• Study Start: June 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)