Heart FailureNCT05726695
The Use of Blood Biochemical Markers for Diagnostics of Heart Muscle Diseases
An observational study of Heart Failure and Heart Dilation, run by University Hospital Ostrava at 1 site in Czechia.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Heart Dilation, Left Ventricular Hypertrophy
- What is being tested?
- microRNA test and Heart ultrasound examination
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jun 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Ostrava
Ostrava-Poruba, Czech Republic, 708 52
About this study
Official title: 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.
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.
- Conditions
- Heart Failure, Heart Dilation, Left Ventricular Hypertrophy
- Being tested
- microRNA test, Heart ultrasound examination
- Keywords
- microRNA, immunomethods, heart failure biomarkers
- Medical subject headings
- Heart Failure, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microRNA testDiagnostic test
Laboratory analysis for the detection of microRNA in blood samples.
Heart ultrasound examinationDiagnostic test
Heart ultrasound examination will be performed as a standard cardiology examination.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: microRNA test; Diagnostic Test: Heart ultrasound examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 43 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Jun 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukáš Evin, MD,Ph.D., Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726695
- Sponsor's protocol ID
- miRNA-RVO-FNOs/2018-05KVO
- Other IDs
- RVO-FNOs/2018-05KVO
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2019
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to make individual participant data available to other researchers.
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 27754357Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.
PubMed 14744438Lim 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 15685193Chen 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 18766170Weber 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 20847327Turchinovich 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 21609964Zernecke 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 19996457Tabet 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 24576947Vickers 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.
PubMed 21423178Arroyo 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 21383194Wang 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 20615901Kosaka 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 20353945Zhu 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 22059153Navickas 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 27357636Heggermont 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of miRNA Detection for Diagnostics of Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT05726695
- Acronym / sponsor ID
- miRNA-RVO-FNOs/2018-05KVO
- Conditions
- Heart Failure, Heart Dilation, Left Ventricular Hypertrophy
- Keywords
- microRNA, immunomethods, heart failure biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure with reduced ejection fraction. | – | Diagnostic Test: microRNA test, Diagnostic Test: Heart ultrasound examinationPatients 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 | – | Diagnostic Test: microRNA test, Diagnostic Test: Heart ultrasound examinationPatients 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microRNA testLaboratory analysis for the detection of microRNA in blood samples. | Diagnostic test | Control group, Heart failure with reduced ejection fraction. |
| Heart ultrasound examinationHeart ultrasound examination will be performed as a standard cardiology examination. | Diagnostic test | Control group, Heart failure with reduced ejection fraction. |
Primary outcome
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.
1 secondary outcome
Correlation between miRNA levels and 1-year mortality and risk of rehospitalization
Time frame: 43 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 27754357Catalanotto 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.
- Background: PubMed 14744438Bartel DP. MicroRNAs: genomics, biogenesis, mechanism, and function. Cell. 2004 Jan 23;116(2):281-97. doi: 10.1016/s0092-8674(04)00045-5.
- Background: PubMed 15685193Lim 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.
- Background: PubMed 18766170Chen 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.
- Background: PubMed 20847327Weber 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.
- Background: PubMed 21609964Turchinovich 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.
- Background: PubMed 19996457Zernecke 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.
- Background: PubMed 24576947Tabet 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.
- Background: PubMed 21423178Vickers 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.
- Background: PubMed 21383194Arroyo 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.
- Background: PubMed 20615901Wang 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.
- Background: PubMed 20353945Kosaka 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.
- Individual participant dataSharing planned: No. The investigators do not plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukáš Evin, MD,Ph.D. principal investigator
University Hospital Ostrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Dilation, run by University Hospital Ostrava at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of miRNA (in pmol/L) (time frame: 43 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05726695, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.