Genetic and Immunity in Heart Failure

NCT06758128 | Recruiting

• 1 other identifier: 6721
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months

Secondary Outcomes (1)

• Genetic polymorphisms and estrogen levels

  6 months

Interventions

Evaluation of HS1,2 polymorphisms GENETIC

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.

Also known as: Cytofluorimetric immunoprofile, Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

ACTIVE NOT RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Genarale e dell'Invecchiamento

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Rossella Cianci

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rossella Cianci

CONTACT

+390630154878; rossella.cianci@policlinicogemelli.it

Study Design

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

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: February 4, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 27, 2025

Record last verified: 2024-12

Locations

IT (2)