Human Leucocyte Antigen G and Chronic Heart Failure

Plasma Levels of Human Leucocyte Antigen G in Patients With 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.

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Diagnostic test: plasmatic HLA-G

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44121
    • Department of Medical Sciences/ Medicine of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

40 subjects with chronic stable heart failure with ejection fraction <40, diagnosed according to the European Society of Cardiology Guidelines

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Chronic Heart Failure (CHF); Entire cohort/ 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	Diagnostic test: plasmatic HLA-G; plasmatic HLA-G by blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure plasma levels of soluble Human Leucocyte Antigen G (HLA-G) in patients with chronic heart failure (CHF)	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	Collection of whole blood at baseline, at 6 and 12 months from baseline
To measure the polymorphisms of Human Leucocyte Antigen G (HLA-G) gene	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	Collection of whole blood at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To correlate the plasma levels of HLA-G with clinical-functional parameters of the chronic heart failure (CHF) in patients with CHF	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	At baseline and after 12 months

Collaborators and Investigators

• Sponsor: Piera Boschetto

Publications and helpful links

General Publications

• Alegre E, Rizzo R, Bortolotti D, Fernandez-Landazuri S, Fainardi E, Gonzalez A. Some basic aspects of HLA-G biology. J Immunol Res. 2014;2014:657625. doi: 10.1155/2014/657625. Epub 2014 Apr 9.
• Almasood A, Sheshgiri R, Joseph JM, Rao V, Kamali M, Tumiati L, Ross HJ, Delgado DH. Human leukocyte antigen-G is upregulated in heart failure patients: a potential novel biomarker. Hum Immunol. 2011 Nov;72(11):1064-7. doi: 10.1016/j.humimm.2011.08.016. Epub 2011 Sep 1.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2017
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): March 31, 2019

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 170687

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No