Investigating the role of clonal hematopoiesis in heart failure
Clonal Hematopoiesis of Indeterminate Potential in Heart Failure - RICO-HF.
This study looks at how changes in blood cell production might affect inflammation and heart problems in people with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Locations | 2 sites (Bergamo and 1 other locations) |
| Trial ID | NCT06626685 on ClinicalTrials.gov |
What this trial studies
This observational study is part of the Rico Macro-Project, which aims to explore the relationship between clonal hematopoiesis and inflammation in various diseases, with a specific focus on heart failure (HF). The study will involve clinical and instrumental examinations of patients admitted for acute HF or attending outpatient clinics for chronic HF. By examining the inflammatory processes linked to clonal hematopoiesis, the study seeks to deepen the understanding of how these mechanisms contribute to cardiac dysfunction. This is the first project to specifically address the connection between clonal hematopoiesis and inflammation in the context of cardiology.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are admitted for acute heart failure or are attending outpatient clinics for chronic heart failure.
Not a fit: Patients with chronic therapy involving anti-inflammatories, recent acute coronary syndrome, or significant non-cardiovascular comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the inflammatory mechanisms of heart failure, potentially improving treatment strategies.
How similar studies have performed: While the specific focus on clonal hematopoiesis in heart failure is novel, related studies have shown the importance of inflammation in cardiac dysfunction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * consecutive patients admitted to the Cardiology Unit of the ASST Papa Giovanni XXIII Hospital, Bergamo for acute HF and patients attending the outpatient HF clinic of the same hospital for chronic HF * age \>18 years * written informed consent Exclusion Criteria: * chronic therapy with anti-inflammatories, steroids, immunomodulators, immunosuppressants, chemotherapeuthic agents * previous heart transplant * cardiogenic shock or cardiac arrest * recent acute coronary syndrome (\<3 months) * current acute infection requiring specific treatment * overt MPNs * primary myelodysplastic syndromes * malignant cancers * non-cardiovascular co-morbidity reducing life expectancy to \< 1 year * any factor precluding 1-year follow-up
Where this trial is running
Bergamo and 1 other locations
- ATS BERGAMO Agenzia di Tutela della Salute — Bergamo, Italy (Active_not_recruiting)
- Asst Papa Giovanni Xxiii - Dip. Di Cardiologia — Bergamo, Italy (Recruiting)
Study contacts
- Study coordinator: Antonello Gavazzi, MD
- Email: agavazzi@fondazionefrom.it
- Phone: +39 0352675134
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.