Investigating the role of clonal hematopoiesis in heart failure
Official title: Clonal Hematopoiesis of Indeterminate Potential in Heart Failure - RICO-HF.
Run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS · NCT06626685 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Locations | 2 sites (Bergamo and 1 other locations) |
| Status | Recruiting |
| Started | March 10, 2025 |
| Main results expected | August 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | July 10, 2026 |
| Trial ID | NCT06626685 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the specific focus on clonal hematopoiesis in heart failure is novel, related studies have shown the importance of inflammation in cardiac dysfunction.
Who can join: the full rules
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 it's running
-
Asst Papa Giovanni Xxiii - Dip. Di Cardiologia
Bergamo, Italy Recruiting -
ATS BERGAMO Agenzia di Tutela della Salute
Bergamo, Italy Active not recruiting
Study contacts
- Study coordinator: Antonello Gavazzi, MD
- Email: agavazzi@fondazionefrom.it
- Phone: +39 0352675134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.