Eicosanoids in Human Heart Failure

Sponsor
University Hospital, Motol (Other)
Overall Status
Recruiting
CT.gov ID
NCT05305170
Collaborator
(none)
100
1
41
2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Levels of EETs, DHETs and HETEs

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Plasmatic Levels of Epoxyeicosatrienoic and Dihydroxyeicosatrienoic Acids in Heart Failure
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
HF

Patients with heart failure.

Diagnostic Test: Levels of EETs, DHETs and HETEs
The plasmatic concentration of EETs, DHETs, and HETEs.

Controls

Controls without heart failure.

Diagnostic Test: Levels of EETs, DHETs and HETEs
The plasmatic concentration of EETs, DHETs, and HETEs.

Outcome Measures

Primary Outcome Measures

  1. Plasmatic levels of eicosanoids [at enrollment]

    EET, DHET, 20-HETE

Secondary Outcome Measures

  1. Mortality [2 years]

    Overall mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Heart failure
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Motol Prague Czechia

Sponsors and Collaborators

  • University Hospital, Motol

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Petr Kala, MD, Petr Kala, MD, University Hospital, Motol
ClinicalTrials.gov Identifier:
NCT05305170
Other Study ID Numbers:
  • UHMotol
First Posted:
Mar 31, 2022
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Petr Kala, MD, Petr Kala, MD, University Hospital, Motol
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022