ClinicalTrials.gg
Status unknownNCT05726695Updated Feb 14, 2023

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

An observational study in Heart Failure, Heart Dilation and Left Ventricular Hypertrophy, sponsored by University Hospital Ostrava. Status unknown at 1 site in Czechia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-02-14.

Sponsored by University Hospital Ostrava · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 165 studies in Heart Failure with a site in Czechia — 35 open to participants now, 43 under way, 14 of them phase 3. Heart Failure · Czechia.

Planned enrollment
19th of 30
200 · median 418
Started
2018
with 11 others
Observational
30 of 165
10 open now
Registered
101st of 165
by date

Among the 165 studies in Heart Failure with a site in Czechia, this one is the 19th largest by planned enrollment of the 30 observational ones that give a count, is one of 12 that started in 2018, is one of 30 observational ones, and was the 101st registered.

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Open to participants now

35 of the 165 studies in Heart Failure with a site in Czechia are open now, in 12 countries. Each count lists the studies.

All 35 open studies →

Who these studies take

Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 165 studies in Heart Failure with a site in Czechia, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Heart Failure
  • Heart Dilation
  • Left Ventricular Hypertrophy

Keywords

  • microRNA
  • immunomethods
  • heart failure biomarkers
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

Inclusion criteria (patient group):

  • left ventricle (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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • Diagnostic testmicroRNA test

    Laboratory analysis for the detection of microRNA in blood samples.

  • Diagnostic testHeart ultrasound examination

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

06

What researchers measure

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.

    Time frame: 43 months

Secondary outcomes

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

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

    Time frame: 43 months

07

Study locations

1 site
  • University Hospital Ostrava
    Ostrava-Poruba, Czech Republic 708 52, Czechia
08

References and documents

Publications

  • Catalanotto C, Cogoni C, Zardo G. MicroRNA in Control of Gene Expression: An Overview of Nuclear Functions. Int J Mol Sci. 2016 Oct 13;17(10):1712. doi: 10.3390/ijms17101712. PubMed 27754357 ↗
  • Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5. PubMed 14744438 ↗
  • Lim LP, Lau NC, Garrett-Engele P, Grimson A, Schelter JM, Castle J, Bartel DP, Linsley PS, Johnson JM. Microarray analysis shows that some microRNAs downregulate large numbers of target mRNAs. Nature. 2005 Feb 17;433(7027):769-73. doi: 10.1038/nature03315. Epub 2005 Jan 30. PubMed 15685193 ↗
  • Chen X, Ba Y, Ma L, Cai X, Yin Y, Wang K, Guo J, Zhang Y, Chen J, Guo X, Li Q, Li X, Wang W, Zhang Y, Wang J, Jiang X, Xiang Y, Xu C, Zheng P, Zhang J, Li R, Zhang H, Shang X, Gong T, Ning G, Wang J, Zen K, Zhang J, Zhang CY. Characterization of microRNAs in serum: a novel class of biomarkers for diagnosis of cancer and other diseases. Cell Res. 2008 Oct;18(10):997-1006. doi: 10.1038/cr.2008.282. PubMed 18766170 ↗
  • Weber JA, Baxter DH, Zhang S, Huang DY, Huang KH, Lee MJ, Galas DJ, Wang K. The microRNA spectrum in 12 body fluids. Clin Chem. 2010 Nov;56(11):1733-41. doi: 10.1373/clinchem.2010.147405. Epub 2010 Sep 16. PubMed 20847327 ↗
  • Turchinovich A, Weiz L, Langheinz A, Burwinkel B. Characterization of extracellular circulating microRNA. Nucleic Acids Res. 2011 Sep 1;39(16):7223-33. doi: 10.1093/nar/gkr254. Epub 2011 May 24. PubMed 21609964 ↗
  • Zernecke A, Bidzhekov K, Noels H, Shagdarsuren E, Gan L, Denecke B, Hristov M, Koppel T, Jahantigh MN, Lutgens E, Wang S, Olson EN, Schober A, Weber C. Delivery of microRNA-126 by apoptotic bodies induces CXCL12-dependent vascular protection. Sci Signal. 2009 Dec 8;2(100):ra81. doi: 10.1126/scisignal.2000610. PubMed 19996457 ↗
  • Tabet F, Vickers KC, Cuesta Torres LF, Wiese CB, Shoucri BM, Lambert G, Catherinet C, Prado-Lourenco L, Levin MG, Thacker S, Sethupathy P, Barter PJ, Remaley AT, Rye KA. HDL-transferred microRNA-223 regulates ICAM-1 expression in endothelial cells. Nat Commun. 2014 Feb 28;5:3292. doi: 10.1038/ncomms4292. PubMed 24576947 ↗
  • Vickers KC, Palmisano BT, Shoucri BM, Shamburek RD, Remaley AT. MicroRNAs are transported in plasma and delivered to recipient cells by high-density lipoproteins. Nat Cell Biol. 2011 Apr;13(4):423-33. doi: 10.1038/ncb2210. Epub 2011 Mar 20. Erratum In: Nat Cell Biol. 2015 Jan;17(1):104. PubMed 21423178 ↗
  • Arroyo JD, Chevillet JR, Kroh EM, Ruf IK, Pritchard CC, Gibson DF, Mitchell PS, Bennett CF, Pogosova-Agadjanyan EL, Stirewalt DL, Tait JF, Tewari M. Argonaute2 complexes carry a population of circulating microRNAs independent of vesicles in human plasma. Proc Natl Acad Sci U S A. 2011 Mar 22;108(12):5003-8. doi: 10.1073/pnas.1019055108. Epub 2011 Mar 7. PubMed 21383194 ↗
  • Wang K, Zhang S, Weber J, Baxter D, Galas DJ. Export of microRNAs and microRNA-protective protein by mammalian cells. Nucleic Acids Res. 2010 Nov;38(20):7248-59. doi: 10.1093/nar/gkq601. Epub 2010 Jul 7. PubMed 20615901 ↗
  • Kosaka N, Iguchi H, Yoshioka Y, Takeshita F, Matsuki Y, Ochiya T. Secretory mechanisms and intercellular transfer of microRNAs in living cells. J Biol Chem. 2010 Jun 4;285(23):17442-52. doi: 10.1074/jbc.M110.107821. Epub 2010 Mar 30. PubMed 20353945 ↗
  • Zhu H, Fan GC. Extracellular/circulating microRNAs and their potential role in cardiovascular disease. Am J Cardiovasc Dis. 2011 Jul 30;1(2):138-149. PubMed 22059153 ↗
  • Navickas R, Gal D, Laucevicius A, Taparauskaite A, Zdanyte M, Holvoet P. Identifying circulating microRNAs as biomarkers of cardiovascular disease: a systematic review. Cardiovasc Res. 2016 Sep;111(4):322-37. doi: 10.1093/cvr/cvw174. Epub 2016 Jun 29. PubMed 27357636 ↗
  • Heggermont WA, Heymans S. MicroRNAs are involved in end-organ damage during hypertension. Hypertension. 2012 Nov;60(5):1088-93. doi: 10.1161/HYPERTENSIONAHA.111.187104. Epub 2012 Sep 17. PubMed 22987922 ↗
  • Ackerman MJ, Priori SG, Willems S, Berul C, Brugada R, Calkins H, Camm AJ, Ellinor PT, Gollob M, Hamilton R, Hershberger RE, Judge DP, Le Marec H, McKenna WJ, Schulze-Bahr E, Semsarian C, Towbin JA, Watkins H, Wilde A, Wolpert C, Zipes DP. HRS/EHRA expert consensus statement on the state of genetic testing for the channelopathies and cardiomyopathies this document was developed as a partnership between the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA). Heart Rhythm. 2011 Aug;8(8):1308-39. doi: 10.1016/j.hrthm.2011.05.020. No abstract available. PubMed 21787999 ↗
  • Jiao M, You HZ, Yang XY, Yuan H, Li YL, Liu WX, Jin M, Du J. Circulating microRNA signature for the diagnosis of childhood dilated cardiomyopathy. Sci Rep. 2018 Jan 15;8(1):724. doi: 10.1038/s41598-017-19138-4. PubMed 29335596 ↗
  • Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available. Erratum In: Eur Heart J. 2018 Mar 7;39(10):860. doi: 10.1093/eurheartj/ehw383. PubMed 27206819 ↗
  • Joladarashi D, Thandavarayan RA, Babu SS, Krishnamurthy P. Small engine, big power: microRNAs as regulators of cardiac diseases and regeneration. Int J Mol Sci. 2014 Sep 9;15(9):15891-911. doi: 10.3390/ijms150915891. PubMed 25207600 ↗
  • Zhang Y, Liu YJ, Liu T, Zhang H, Yang SJ. Plasma microRNA-21 is a potential diagnostic biomarker of acute myocardial infarction. Eur Rev Med Pharmacol Sci. 2016;20(2):323-9. PubMed 26875904 ↗
  • Thum T, Gross C, Fiedler J, Fischer T, Kissler S, Bussen M, Galuppo P, Just S, Rottbauer W, Frantz S, Castoldi M, Soutschek J, Koteliansky V, Rosenwald A, Basson MA, Licht JD, Pena JT, Rouhanifard SH, Muckenthaler MU, Tuschl T, Martin GR, Bauersachs J, Engelhardt S. MicroRNA-21 contributes to myocardial disease by stimulating MAP kinase signalling in fibroblasts. Nature. 2008 Dec 18;456(7224):980-4. doi: 10.1038/nature07511. Epub 2008 Nov 30. PubMed 19043405 ↗
  • Bang C, Batkai S, Dangwal S, Gupta SK, Foinquinos A, Holzmann A, Just A, Remke J, Zimmer K, Zeug A, Ponimaskin E, Schmiedl A, Yin X, Mayr M, Halder R, Fischer A, Engelhardt S, Wei Y, Schober A, Fiedler J, Thum T. Cardiac fibroblast-derived microRNA passenger strand-enriched exosomes mediate cardiomyocyte hypertrophy. J Clin Invest. 2014 May;124(5):2136-46. doi: 10.1172/JCI70577. Epub 2014 Apr 17. PubMed 24743145 ↗

Individual participant data

Plan to share: No — The investigators do not plan to make individual participant data available to other researchers.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2018 to primary completion in Dec 2022, 54 months.

Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's 54 months is above that.

Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 1, 2019
First posted
Feb 14, 2023
StartActual
Jun 1, 2018
Primary completionActual
Dec 31, 2022
CompletionEst.
Dec 31, 2023
Last update
Feb 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05726695
Responsible party
Sponsor
First posted
Feb 14, 2023
Start date
Jun 1, 2018
Primary completion
Dec 31, 2022
Completion
Dec 31, 2023 (estimated)
Last update
Feb 14, 2023

Study contacts

Lukáš Evin, MD,Ph.D.
principal investigator · University Hospital Ostrava

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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