Human Leucocyte Antigen G and Chronic Heart Failure

NCT ID: NCT03655925

Last Updated: 2019-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-11

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Chronic Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

plasmatic HLA-G

Intervention Type DIAGNOSTIC_TEST

plasmatic HLA-G by blood sample

Interventions

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plasmatic HLA-G

plasmatic HLA-G by blood sample

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Piera Boschetto

OTHER

Sponsor Role lead

Responsible Party

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Piera Boschetto

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Medical Sciences/ Medicine of Public Health

Ferrara, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 24818168 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21925559 (View on PubMed)

Other Identifiers

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170687

Identifier Type: -

Identifier Source: org_study_id

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