Chronic Heart FailureNCT03655925
Human Leucocyte Antigen G and Chronic Heart Failure
An observational study of Chronic Heart Failure, run by Piera Boschetto at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- plasmatic HLA-G
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 11 Oct 2017to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 40 subjects with chronic stable heart failure with ejection fraction <40, diagnosed according to the European Society of Cardiology Guidelines
Who may be able to join
- 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.
Who cannot join
- Subjects with over one year chronic heart failure diagnosis and in clinical stability for less than 1 month.
- Presence of autoimmune diseases.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Medical Sciences/ Medicine of Public Health
Ferrara, 44121
About this study
Official title: 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.
- Conditions
- Chronic Heart Failure
- Being tested
- plasmatic HLA-G
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasmatic HLA-GDiagnostic test
plasmatic HLA-G by blood sample
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: plasmatic HLA-G |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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
Measured: At baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start11 Oct 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piera Boschetto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Piera Boschetto, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655925
- Sponsor's protocol ID
- 170687
- Status last verified
- Apr 2019
- First submitted
- 25 Jul 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 24818168Almasood 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.
PubMed 21925559
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Levels of Human Leucocyte Antigen G in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03655925
- Acronym / sponsor ID
- 170687
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Piera BoschettoUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Chronic Heart Failure (CHF) | – | Diagnostic Test: plasmatic HLA-GEntire 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 40 subjects with chronic stable heart failure with ejection fraction <40, diagnosed according to the European Society of Cardiology Guidelines
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Subjects with over one year chronic heart failure diagnosis and in clinical stability for less than 1 month.
- Presence of autoimmune diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasmatic HLA-Gplasmatic HLA-G by blood sample | Diagnostic test | Patients with Chronic Heart Failure (CHF) |
Primary outcome
To measure plasma levels of soluble Human Leucocyte Antigen G (HLA-G) in patients with chronic heart failure (CHF)
Time frame: 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
To measure the polymorphisms of Human Leucocyte Antigen G (HLA-G) gene
Time frame: 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
1 secondary outcome
To correlate the plasma levels of HLA-G with clinical-functional parameters of the chronic heart failure (CHF) in patients with CHF
Time frame: At baseline and after 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Background: PubMed 24818168Alegre 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.
- Background: PubMed 21925559Almasood 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Piera Boschetto at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure plasma levels of soluble Human Leucocyte Antigen G (HLA-G) in patients with chronic heart failure (CHF) (time frame: Collection of whole blood at baseline, at 6 and 12 months from baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03655925, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.