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Heart FailureNCT05305170

Eicosanoids in Human Heart Failure

An observational study of Heart Failure, run by University Hospital, Motol at 1 site in Czechia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Our translational project aims to evaluate the role of eicosanoids in human HF. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Heart Failure
What is being tested?
Levels of EETs, DHETs and HETEs
How many people
100 participants
Where
1 siteCzechia
Study dates
1 Aug 2021to 31 Dec 2024
How long will I take part?
2 Years
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Heart failure patients from our tertiary cardiovascular center and controls from the central hospital laboratory.

Who may be able to join

  • Heart failure

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Czechia1 site, 1 recruiting

  • University Hospital Motol

    Prague

    Petr Kala, MD, 00420702024181, petr.kala@fnmotol.cz

    Recruiting

Other trials in Czechia

About this study

Official title: Plasmatic Levels of Epoxyeicosatrienoic and Dihydroxyeicosatrienoic Acids in Heart Failure

Our translational project aims to evaluate the role of eicosanoids in human HF.

Read the detailed description

Heart failure (HF) is the leading cause of cardiovascular hospitalizations, and with its increasing prevalence, the healthcare systems face a heart failure pandemic. Translational research findings improve our knowledge of pathophysiology and uncover therapeutic targets in HF. Natriuretic peptides represent such examples as routinely used in diagnostics and therapeutics (neprilysin inhibitor). Despite modern pharmacotherapy, including angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitors (SGLT2i), the prognosis of patients, especially with advanced heart failure, remains poor. Furthermore, most medication is limited in the late stages of HF due to their hypotensive effects.

Basic research has been focused on the eicosanoids - metabolites of cytochrome P-450 (CYP)-dependent epoxygenase pathway of arachidonic acid (AA), especially epoxyeicosatrienoic acids (EETs). In the preclinical studies, it was shown that EETs importantly contribute to the regulation of cardiovascular and renal function and exert organ-protective actions. It was also proposed that intrarenal EETs operate as an endogenous compensatory system opposing increased renin-angiotensin system (RAS) activity. EETs are rapidly transformed by soluble epoxide hydrolase (sEH) to biologically inactive dihydroxyeicosatrienoic acids (DHETs). The role of eicosanoids in human HF, however, remains unclear.

Our translational project (Eicosanoids in Human Heart Failure) aims to evaluate the role of eicosanoids in human HF.

Conditions
Heart Failure
Being tested
Levels of EETs, DHETs and HETEs
Keywords
heart failure, eicosanoids, reverse remodeling
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Levels of EETs, DHETs and HETEsDiagnostic test

    The plasmatic concentration of EETs, DHETs, and HETEs.

Study groups in NCT05305170
Study groupRoleWhat they receive
HFPatients with heart failure.
Receives: Diagnostic Test: Levels of EETs, DHETs and HETEs
ControlsControls without heart failure.
Receives: Diagnostic Test: Levels of EETs, DHETs and HETEs

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasmatic levels of eicosanoids

    EET, DHET, 20-HETE

    Measured: at enrollment

Secondary outcomes (1)

  1. Mortality

    Overall mortality

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start1 Aug 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05305170
Sponsor's protocol ID
UHMotol
Status last verified
Mar 2022
First submitted
22 Mar 2022
Last updated
8 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.

    PubMed 29174292

  • McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.

    PubMed 34447992

  • Vaduganathan M, Claggett BL, Jhund PS, Cunningham JW, Pedro Ferreira J, Zannad F, Packer M, Fonarow GC, McMurray JJV, Solomon SD. Estimating lifetime benefits of comprehensive disease-modifying pharmacological therapies in patients with heart failure with reduced ejection fraction: a comparative analysis of three randomised controlled trials. Lancet. 2020 Jul 11;396(10244):121-128. doi: 10.1016/S0140-6736(20)30748-0. Epub 2020 May 21.

    PubMed 32446323

  • Imig JD, Cervenka L, Neckar J. Epoxylipids and soluble epoxide hydrolase in heart diseases. Biochem Pharmacol. 2022 Jan;195:114866. doi: 10.1016/j.bcp.2021.114866. Epub 2021 Dec 2.

    PubMed 34863976

  • Fan F, Roman RJ. Effect of Cytochrome P450 Metabolites of Arachidonic Acid in Nephrology. J Am Soc Nephrol. 2017 Oct;28(10):2845-2855. doi: 10.1681/ASN.2017030252. Epub 2017 Jul 12.

    PubMed 28701518

  • Jamieson KL, Endo T, Darwesh AM, Samokhvalov V, Seubert JM. Cytochrome P450-derived eicosanoids and heart function. Pharmacol Ther. 2017 Nov;179:47-83. doi: 10.1016/j.pharmthera.2017.05.005. Epub 2017 May 25.

    PubMed 28551025

  • Elmarakby AA. Reno-protective mechanisms of epoxyeicosatrienoic acids in cardiovascular disease. Am J Physiol Regul Integr Comp Physiol. 2012 Feb 1;302(3):R321-30. doi: 10.1152/ajpregu.00606.2011. Epub 2011 Nov 23.

    PubMed 22116511

  • Sporkova A, Reddy RN, Falck JR, Imig JD, Kopkan L, Sadowski J, Cervenka L. Interlobular Arteries From 2-Kidney, 1-Clip Goldblatt Hypertensive Rats' Exhibit-Impaired Vasodilator Response to Epoxyeicosatrienoic Acids. Am J Med Sci. 2016 May;351(5):513-9. doi: 10.1016/j.amjms.2016.02.030. Epub 2016 Feb 23.

    PubMed 27140711

  • Fleming I. The pharmacology of the cytochrome P450 epoxygenase/soluble epoxide hydrolase axis in the vasculature and cardiovascular disease. Pharmacol Rev. 2014 Oct;66(4):1106-40. doi: 10.1124/pr.113.007781.

    PubMed 25244930

  • Imig JD, Elmarakby A, Nithipatikom K, Wei S, Capdevila JH, Tuniki VR, Sangras B, Anjaiah S, Manthati VL, Sudarshan Reddy D, Falck JR. Development of epoxyeicosatrienoic acid analogs with in vivo anti-hypertensive actions. Front Physiol. 2010 Dec 3;1:157. doi: 10.3389/fphys.2010.00157. eCollection 2010.

    PubMed 21423396

  • Gawrys O, Huskova Z, Baranowska I, Walkowska A, Sadowski J, Kikerlova S, Vanourkova Z, Honetschlagerova Z, Skaroupkova P, Cervenka L, Falck JR, Imig JD, Kompanowska-Jezierska E. Combined treatment with epoxyeicosatrienoic acid analog and 20-hydroxyeicosatetraenoic acid antagonist provides substantial hypotensive effect in spontaneously hypertensive rats. J Hypertens. 2020 Sep;38(9):1802-1810. doi: 10.1097/HJH.0000000000002462.

    PubMed 32384390

  • Kala P, Miklovic M, Jichova S, Skaroupkova P, Vanourkova Z, Maxova H, Gawrys O, Kompanowska-Jezierska E, Sadowski J, Imig JD, Falck JR, Veselka J, Cervenka L, Aiglova R, Vicha M, Gloger V, Taborsky M. Effects of Epoxyeicosatrienoic Acid-Enhancing Therapy on the Course of Congestive Heart Failure in Angiotensin II-Dependent Rat Hypertension: From mRNA Analysis towards Functional In Vivo Evaluation. Biomedicines. 2021 Aug 20;9(8):1053. doi: 10.3390/biomedicines9081053.

    PubMed 34440257

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by University Hospital, Motol 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 1 inclusion and 1 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 8 Apr 2022. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Plasmatic levels of eicosanoids (time frame: at enrollment). 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 NCT05305170, which also lists 12 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 8 Apr 2022.

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