Skip to content

Human Leucocyte Antigen G and Chronic Heart Failure

Plasma Levels of Human Leucocyte Antigen G in Patients With Chronic Heart Failure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03655925
Enrollment
40
Registered
2018-08-31
Start date
2017-10-11
Completion date
2019-03-31
Last updated
2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure

Brief summary

The Human leukocyte antigen G (HLA-G) is a non-classical, major histocompatibility complex class I (MHC-I) protein that modulates the immune response, inhibiting it in most cases. Physiologically expressed in the cells of some tissues, it increases in inflammatory reactions. Inflammation appears to play an important role in the development of chronic heart failure. This study aims to evaluate the levels of soluble HLA-G in patients with heart failure and to investigate the relationships between HLA-G and other clinical-functional parameters of the disease. Investigators hypothesize that the plasma levels of HLA-G could correlate with the clinical status of heart failure and could provide indications on patient's prognosis.

Interventions

DIAGNOSTIC_TESTplasmatic HLA-G

plasmatic HLA-G by blood sample

Sponsors

Piera Boschetto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients with recent diagnosis of chronic heart failure as defined by the guidelines of the European Society of Cardiology (ESC) and with cardiac ejection fraction \<40. * Clinical stability in the previous month prior to recruitment. * Absence of coexisting autoimmune diseases.

Exclusion criteria

* Subjects with over one year chronic heart failure diagnosis and in clinical stability for less than 1 month. * Presence of autoimmune diseases.

Design outcomes

Primary

MeasureTime frameDescription
To measure plasma levels of soluble Human Leucocyte Antigen G (HLA-G) in patients with chronic heart failure (CHF)Collection of whole blood at baseline, at 6 and 12 months from baselineTo measure the plasmatic levels of HLA-G in patients with stable chronic heart failure at baseline. To assess possible changes in HLA-G levels, due to CHF exacerbations, at 6 and 12 months from baseline
To measure the polymorphisms of Human Leucocyte Antigen G (HLA-G) geneCollection of whole blood at baselineTo analyze the polymorphisms (Insertion/Deletion 14 pb and 3142 C\>G) of the HLA-G gene in patients with chronic heart failure (CHF) at baseline

Secondary

MeasureTime frameDescription
To correlate the plasma levels of HLA-G with clinical-functional parameters of the chronic heart failure (CHF) in patients with CHFAt baseline and after 12 monthsTo correlate plasma levels of HLA-G with Brain Natriuretic Peptide (BNP) and left ventricle ejection fraction at baseline and at 12 months from baseline

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026