Clonal Hematopoiesis of Indeterminate Potential in Heart Failure. (RICO-HF)

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Status: Enrolling

Conditions: Heart Failure

Treatments: Other: Clinical and instrumental examination

Study type: Observational

Funder types: Other

Identifiers

NCT06626685

RICO-HF

Details and patient eligibility

About

This study is part of the Rico Macro-Project, a multidisciplinary research program promoted by FROM in collaboration with the ASST-PG23 and ATS Bergamo, aiming to investigate the role of clonal hematopoiesis on inflammation, studying in depth the mechanisms underlying the inflammatory process to determine their correlation with some important pathologies in different clinical fields (Hematology, Cardiology, Neurology, Pneumology, Gastroenterology, and Diabetology, etc.). In this context, the prospective observational study RICO-HF is developed.

The RICO HF is the first project focused on CHIP and inflammation in the area of Cardiology, specifically in HF.

Full description

CHIP is associated with a pro-inflammatory state and its mechanistic link to HF has been demonstrated in animal and cellular models, and in patient cohorts (14-24).

Although HF in humans has various causes, different pathophysiological mechanisms and heterogeneous clinical manifestations, the experimental and clinical data reported so far support the relevance of inflammatory cytokine production and signaling by immune cells in the pathogenesis of cardiac dysfunction and HF.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Acute Heart Failure

Description:

Patients hospitalized with acute HF classified according to LVEF.

Treatment:

Other: Clinical and instrumental examination

Chronic Heart Failure

Description:

Ambulatory patients with chronic HF classified according to LVEF.

Treatment:

Other: Clinical and instrumental examination