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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute Heart Failure | Patients hospitalized with acute HF classified according to LVEF. |
| |
| Chronic Heart Failure | Ambulatory patients with chronic HF classified according to LVEF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical and instrumental examination | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the prevalence of CHIP in patients with a diagnosis of acute HF according to the value of LVEF>50% (HFpEF) or ≤50% (HFmrEF/HFrEF) at the time of hospitalization. | Obtained by medical health records | At diagnosis during the baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions | Obtained by medical health records | At baseline; 1 year follow-up. |
| Estimation of CHIP prevalence in HF patients, according to the acute or chronic conditions and classified by LVEF |
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Inclusion Criteria:
Exclusion Criteria:
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Patients consecutively afferent to the SC Cardiologia I of the ASST-PG23 Hospital in Bergamo with the diagnosis of acute or chronic Heart Failure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonello Gavazzi, MD | Contact | +39 0352675134 | agavazzi@fondazionefrom.it | |
| FENILI | Contact | sperimentazioni@fondazionefrom.it |
| Name | Affiliation | Role |
|---|---|---|
| ANTONELLO GAVAZZI, MD | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATS BERGAMO Agenzia di Tutela della Salute | Active, not recruiting | Bergamo | 24121 | Italy | ||
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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The study of clonal hematopoiesis requires the use of sequencing technologies, as the Next Generation Sequencing (NGS), currently employed in the diagnosis and therapy of solid tumors and hematological malignancies.
Obtained by medical health records |
| At baseline; 1 year follow-up. |
| Association between CHIP and patterns of inflammatory biomarkers in patients with acute de novo HFpEF | Obtained by medical health records | At baseline; 1 year follow-up. |
| Association between CHIP and outcome (mortality, urgent heart transplant, HF hospitalization and need for urgent visit due to HF decompensation) | Obtained by medical health records | At baseline; 1 year follow-up. |
| Association between CHIP and patients' clinical characteristics at baseline | Obtained by medical health records | At baseline; 1 year follow-up. |
| Asst Papa Giovanni Xxiii - Dip. Di Cardiologia |
| Recruiting |
| Bergamo |
| 24127 |
| Italy |
|