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

February 9, 2023 updated by: University Hospital Ostrava

The Use of miRNA Detection for Diagnostics of Cardiovascular Diseases

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Ostrava-Poruba, Czech Republic, Czechia, 708 52
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of miRNA (in pmol/L)
Time Frame: 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.
43 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between miRNA levels and 1-year mortality and risk of rehospitalization
Time Frame: 43 months
We will examine levels of miRNA in corelation to 1-year mortality and risk of rehospitalization acquired from Czech national registry (UZIS).
43 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Lukáš Evin, MD,Ph.D., University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ACTUAL)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

February 9, 2023

First Posted (ESTIMATE)

February 14, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • miRNA-RVO-FNOs/2018-05KVO
  • RVO-FNOs/2018-05KVO (OTHER_GRANT: University Hospital Ostrava)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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