Human Leucocyte Antigen G and Chronic Heart Failure

Completed

• Conditions: Chronic Heart Failure
• Interventions: Diagnostic Test: plasmatic HLA-G

• Registration Number: NCT03655925
• Lead Sponsor: Piera Boschetto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2018-07-25
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Primary Completion: 2019-03-31
• Study Completion: 2019-03-31
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Chronic Heart Failure (CHF)	plasmatic HLA-G	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

Primary Outcome Measures

Name	Time	Method
To measure the polymorphisms of Human Leucocyte Antigen G (HLA-G) gene	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
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 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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Medical Sciences/ Medicine of Public Health; 🇮🇹 Ferrara, Italy