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Completed

NCT Number: NCT03655925

Human Leucocyte Antigen G and Chronic Heart Failure

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.

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Key information

Conditions

Chronic Heart Failure

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Medical Sciences/ Medicine of Public Health

Ferrara, 44121, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

plasmatic HLA-G

Diagnostic Test

plasmatic HLA-G by blood sample

Primary outcomes

  1. To measure plasma levels of soluble Human Leucocyte Antigen G (HLA-G) in patients with chronic heart failure (CHF)

    Time frame: Collection of whole blood at baseline, at 6 and 12 months from baseline

    To 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

  2. To measure the polymorphisms of Human Leucocyte Antigen G (HLA-G) gene

    Time frame: Collection of whole blood at baseline

    To 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 outcomes

  1. To correlate the plasma levels of HLA-G with clinical-functional parameters of the chronic heart failure (CHF) in patients with CHF

    Time frame: At baseline and after 12 months

    To correlate plasma levels of HLA-G with Brain Natriuretic Peptide (BNP) and left ventricle ejection fraction at baseline and at 12 months from baseline

Sponsors and collaborators

Lead sponsor

Piera Boschetto

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
Apr 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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