Heart FailureGISCONCT06758128
Genetic and Immunity in Heart Failure
An observational study of Heart Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
Heart failure is a major health problem with serious consequences on mortality and morbidity worldwide. In chronic heart failure an alteration of the inflammatory state occur. The aim of this study will be to describe the relationship between markers of inflammation in patients with heart failure with preserved… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Evaluation of HS1,2 polymorphisms
- How many people
- 215 participants
- Where
- 2 sitesItaly
- Study dates
- 4 Feb 2025to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study sample will include adult patients (>18 years) hospitalized in the Unit of General Medicine and Aging with a diagnosis of heart failure based on the guidelines on heart failure. Clinical and demographic data will be collected from the electronic records of our hospital information system. The medical record of each patient will be used to record demographic and clinical characteristics, data relating to the presentation in the Emergency Department, the evaluation and any event that occurred during hospitalization, including the conditions at discharge.
Who may be able to join
- Adult patients (age ≥18 years) with exacerbation of chronic heart failure with reduced or preserved ejection fraction,
- stable haemodynamic conditions, without the need for inotropic support at the time of admission to the ward,
- signature of the informed consent.
Who cannot join
- . age <18 years;
- pregnancy;
- acute coronary syndromes;
- end-stage renal failure (clearance <30 mL/min) or dialysis;
- ongoing sepsis;
- bed rest syndrome;
- any concomitant neoplasm,
- congenital and acquired immunodeficiencies (HIV, immunosuppressive drugs).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Genarale e dell'Invecchiamento
Rome, Lazio, 00168
Rossella Cianci, +390630154878, rossella.cianci@policlinicogemelli.it
Rossella Cianci
- Active, not recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia
About this study
Official title: Role of Immunity and Genetic Predisposition in Chronic Heart Failure Exacerbation
Heart failure is a major health problem with serious consequences on mortality and morbidity worldwide. In chronic heart failure an alteration of the inflammatory state occur. The aim of this study will be to describe the relationship between markers of inflammation in patients with heart failure with preserved ejection fraction, gender differences and advanced age.
The study sample will include patients hospitalized in the Unit of General Medicine and Aging with a diagnosis of heart failure based on the guidelines. Clinical and demographic data will be collected from the electronic records of our hospital system. A complete history will be obtained, including the possible etiology of heart failure, cardiac and noncardiac comorbidities, all medications, intracardiac devices, and chronic oxygen treatment. All patients will be documented for peripheral edema, pulmonary rales and jugular vein distension. NYHA (New York Heart Association) class will be identified at discharge. In addition, a blood sample will be taken to obtain a complete panel including total blood count, glycemia, renal function, electrolytes and liver function tests, as per standardized clinical practice. NT-proBNP (Amino-terminal pro Natriuretic Peptide B) will be measured at admission and discharge from the hospital, as per standardized clinical practice.
Read more
Echocardiograms will be performed by experienced operators of the echocardiography service of our Polyclinic, according to the American Society of Echocardiography guidelines.
A single additional blood sample will be collected during one of the normal routine blood draws for all immunological tests. Plasma from each participant will be isolated to determine the concentrations of several cytokines. Circulating lymphocytes will be separated according to Ficoll gradient (peripheral blood mononuclear cells, PBMC) into the two different components of immunity (B and T lymphocytes) with different inflammatory phenotypes Evaluation of enhancer (HS)1,2 polymorphisms and estrogen levels: DNA purifications and amplifications will be performed from an aliquot of the single whole blood sample collected for the evaluation of the inflammatory profile. Genomic DNA will be isolated and 9 SNPs in four specific polymorphic regions of the 3'-1 Regulatory Region (3'RR-1) of the human immunoglobulin (IgH) heavy chain locus will be sequenced. Follow-up will be performed by telephone contacting the patients or their caregivers 90 days after discharge.
- Conditions
- Heart Failure
- Being tested
- Evaluation of HS1,2 polymorphisms
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of HS1,2 polymorphismsGenetic
Also called Cytofluorimetric immunoprofile, Echocardiography
Echocardiograms will be performed by experienced operators of the echocardiography service.
Inflammatory profile. A single additional blood sample (3 cc) will be collected. Plasma will be isolated from whole blood to determine pro-inflammatory cytokines.
Immunoprofile: Circulating lymphocytes will be separated according to Ficoll gradient (into the two different components of immunity (B and T lymphocytes) with different inflammatory phenotypes.
Evaluation of HS1,2 polymorphisms and estrogen levels: DNA purifications and amplifications will be performed from an aliquot of the single whole blood sample. Genomic DNA will be isolated using the QIAamp DNA Mini and Blood Mini kit (QIAGEN Hilden, Germany) according to the manufacturer's protocol. 9 single nucleotide polymorphisms (SNPs) in four specific polymorphic regions of the 3'-1 Regulatory Region (3'RR-1) of the human immunoglobulin (IgH) heavy chain locus will be sequenced.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HS1,2 enhancer alleles of human immunoglobulin heavy chains in patients with heart failure
Difference in the prevalence of HS1,2 enhancer alleles of human immunoglobulin heavy chains in patients with heart failure with preserved ejection fraction and in patients with heart failure with reduced ejection fraction.
Measured: 6 months
Inflammatory markers in heart failure
To evaluate any differences in inflammatory markers in patients with heart failure with preserved ejection fraction and reduced ejection fraction, with particular attention to gender and age differences.
Measured: 6 months
Secondary outcomes (1)
Genetic polymorphisms and estrogen levels
Evaluate the association between different genetic polymorphisms and estrogen levels in different models of patients with chronic heart failure with preserved and reduced ejection fraction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start4 Feb 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- 215 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rossella Cianci, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758128
- Sponsor's protocol ID
- 6721
- Acronym
- GISCO
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Immunity and Genetic Predisposition in Chronic Heart Failure Exacerbation
- ClinicalTrials.gov ID
- NCT06758128
- Acronym / sponsor ID
- GISCO / 6721
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 3 Jan 2025 (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.
Heart failure is a major health problem with serious consequences on mortality and morbidity worldwide. In chronic heart failure an alteration of the inflammatory state occur. The aim of this study will be to describe the relationship between markers of inflammation in patients with heart failure with preserved ejection fraction, gender differences and advanced age.
The study sample will include patients hospitalized in the Unit of General Medicine and Aging with a diagnosis of heart failure based on the guidelines. Clinical and demographic data will be collected from the electronic records of our hospital system. A complete history will be obtained, including the possible etiology of heart failure, cardiac and noncardiac comorbidities, all medications, intracardiac devices, and chronic oxygen treatment. All patients will be documented for peripheral edema, pulmonary rales and jugular vein distension. NYHA (New York Heart Association) class will be identified at discharge. In addition, a blood sample will be taken to obtain a complete panel including total blood count, glycemia, renal function, electrolytes and liver function tests, as per standardized clinical practice. NT-proBNP (Amino-terminal pro Natriuretic Peptide B) will be measured at admission and discharge from the hospital, as per standardized clinical practice.
Echocardiograms will be performed by experienced operators of the echocardiography service of our Polyclinic, according to the American Society of Echocardiography guidelines.
A single additional blood sample will be collected during one of the normal routine blood draws for all immunological tests. Plasma from each participant will be isolated to determine the concentrations of several cytokines. Circulating lymphocytes will be separated according to Ficoll gradient (peripheral blood mononuclear cells, PBMC) into the two different components of immunity (B and T lymphocytes) with different inflammatory phenotypes Evaluation of enhancer (HS)1,2 polymorphisms and estrogen levels: DNA purifications and amplifications will be performed from an aliquot of the single whole blood sample collected for the evaluation of the inflammatory profile. Genomic DNA will be isolated and 9 SNPs in four specific polymorphic regions of the 3'-1 Regulatory Region (3'RR-1) of the human immunoglobulin (IgH) heavy chain locus will be sequenced. Follow-up will be performed by telephone contacting the patients or their caregivers 90 days after discharge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample will include adult patients (>18 years) hospitalized in the Unit of General Medicine and Aging with a diagnosis of heart failure based on the guidelines on heart failure. Clinical and demographic data will be collected from the electronic records of our hospital information system. The medical record of each patient will be used to record demographic and clinical characteristics, data relating to the presentation in the Emergency Department, the evaluation and any event that occurred during hospitalization, including the conditions at discharge.
Key inclusion criteria (3 listed)
- Adult patients (age ≥18 years) with exacerbation of chronic heart failure with reduced or preserved ejection fraction,
- stable haemodynamic conditions, without the need for inotropic support at the time of admission to the ward,
- signature of the informed consent.
Key exclusion criteria (8 listed)
- . age <18 years;
- pregnancy;
- acute coronary syndromes;
- end-stage renal failure (clearance <30 mL/min) or dialysis;
- ongoing sepsis;
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 |
|---|---|---|
| Evaluation of HS1,2 polymorphismsAlso: Cytofluorimetric immunoprofile, EchocardiographyEchocardiograms will be performed by experienced operators of the echocardiography service. Inflammatory profile. A single additional blood sample (3 cc) will be collected. Plasma will be isolated from whole blood to determine pro-inflammatory cytokines. Immunoprofile: Circulating lymphocytes will be separated according to Ficoll gradient (into the two different components of immunity (B and T lymphocytes) with different inflammatory phenotypes. Evaluation of HS1,2 polymorphisms and estrogen levels: DNA purifications and amplifications will be performed from an aliquot of the single whole blood sample. Genomic DNA will be isolated using the QIAamp DNA Mini and Blood Mini kit (QIAGEN Hilden, Germany) according to the manufacturer's protocol. 9 single nucleotide polymorphisms (SNPs) in four specific polymorphic regions of the 3'-1 Regulatory Region (3'RR-1) of the human immunoglobulin (IgH) heavy chain locus will be sequenced. | Genetic | – |
Primary outcome
Prevalence of HS1,2 enhancer alleles of human immunoglobulin heavy chains in patients with heart failure
Time frame: 6 months
Difference in the prevalence of HS1,2 enhancer alleles of human immunoglobulin heavy chains in patients with heart failure with preserved ejection fraction and in patients with heart failure with reduced ejection fraction.
Inflammatory markers in heart failure
Time frame: 6 months
To evaluate any differences in inflammatory markers in patients with heart failure with preserved ejection fraction and reduced ejection fraction, with particular attention to gender and age differences.
1 secondary outcome
Genetic polymorphisms and estrogen levels
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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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.
Rossella Cianci principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rossella Cianci (+390630154878, rossella.cianci@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HS1,2 enhancer alleles of human immunoglobulin heavy chains in patients with heart failure (time frame: 6 months). 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?
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 27 Mar 2025.