Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-10

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Heart Failure

Patients hospitalized with acute HF classified according to LVEF.

Clinical and instrumental examination

Intervention Type OTHER

Each patient, consecutively afferent to the SC Cardiologia I of the ASST-PG23 in Bergamo with the diagnosis of acute or chronic HF, at enrollment will undergo to routine clinical and instrumental examination.

Chronic Heart Failure

Ambulatory patients with chronic HF classified according to LVEF.

Clinical and instrumental examination

Intervention Type OTHER

Each patient, consecutively afferent to the SC Cardiologia I of the ASST-PG23 in Bergamo with the diagnosis of acute or chronic HF, at enrollment will undergo to routine clinical and instrumental examination.

Interventions

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Clinical and instrumental examination

Each patient, consecutively afferent to the SC Cardiologia I of the ASST-PG23 in Bergamo with the diagnosis of acute or chronic HF, at enrollment will undergo to routine clinical and instrumental examination.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No