Exploring genetic and immune factors in heart failure
Role of Immunity and Genetic Predisposition in Chronic Heart Failure Exacerbation
This study looks at how inflammation and genetic factors affect heart failure in older adults, especially focusing on differences between men and women.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 215 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (San Giovanni Rotondo, Foggia and 1 other locations) |
| Trial ID | NCT06758128 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between inflammatory markers and heart failure with preserved ejection fraction, focusing on gender differences and advanced age. It will involve adult patients hospitalized for chronic heart failure, collecting clinical and demographic data from electronic health records. The study will document various clinical parameters, including comorbidities and NYHA class, to better understand the inflammatory state in these patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with exacerbated chronic heart failure who are stable and not requiring inotropic support.
Not a fit: Patients under 18, pregnant women, those with acute coronary syndromes, or severe renal failure are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of heart failure, particularly in older adults and women.
How similar studies have performed: While the specific approach may be novel, studies investigating inflammation in heart failure have shown promising results in understanding the condition.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
San Giovanni Rotondo, Foggia and 1 other locations
- 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, Italy (Recruiting)
Study contacts
- Principal investigator: Rossella Cianci — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Rossella Cianci
- Email: rossella.cianci@policlinicogemelli.it
- Phone: +390630154878
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.