Human Leucocyte Antigen G and Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655925
• Other study ID #: 170687
• Status: Completed
• Start date: October 11, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Diagnostic Test:
• plasmatic HLA-G
plasmatic HLA-G by blood sample

Locations

Country	Name	City	State
Italy	Department of Medical Sciences/ Medicine of Public Health	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
Piera Boschetto

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Alegre E, Rizzo R, Bortolotti D, Fernandez-Landázuri S, Fainardi E, González A. Some basic aspects of HLA-G biology. J Immunol Res. 2014;2014:657625. doi: 10.1155/2014/657625. Epub 2014 Apr 9. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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