Human Leucocyte Antigen G and Chronic Heart Failure

NCT03655925 | Completed

• 1 other identifier: 170687
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Study Arms (1)

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

Interventions

plasmatic HLA-G DIAGNOSTIC_TEST

plasmatic HLA-G by blood sample

Patients with Chronic Heart Failure (CHF)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Piera Boschetto: lead

Study Sites (1)

Department of Medical Sciences/ Medicine of Public Health

Ferrara, 44121, Italy

Location

Related Publications (2)

• 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.

  PMID: 24818168 BACKGROUND

• 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.

  PMID: 21925559 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 31, 2018
• Study Start: October 11, 2017
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Locations

IT (1)