| NCT ID | NCT06758128 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 215 participants |
| Start Date | 2025-02-04 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 215 participants in total. It began in 2025-02-04 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion criteria: * 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. Exclusion criteria: . 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).
Contact & Investigator
Rossella Cianci
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT06758128 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06758128 currently recruiting?
Yes, NCT06758128 is actively recruiting participants. Contact the research team at rossella.cianci@policlinicogemelli.it for enrollment information.
Where is the NCT06758128 trial being conducted?
This trial is being conducted at San Giovanni Rotondo, Italy, Rome, Italy.
Who is sponsoring the NCT06758128 clinical trial?
NCT06758128 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Rossella Cianci at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 215 participants.
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