Heart Failure
Conditions
Brief summary
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.
Detailed 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.
Interventions
OTHERClinical 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.
Sponsors
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | At diagnosis during the baseline | Obtained by medical health records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions | At baseline; 1 year follow-up. | Obtained by medical health records |
| Estimation of CHIP prevalence in HF patients, according to the acute or chronic conditions and classified by LVEF | At baseline; 1 year follow-up. | Obtained by medical health records |
| Association between CHIP and patterns of inflammatory biomarkers in patients with acute de novo HFpEF | At baseline; 1 year follow-up. | Obtained by medical health records |
| Association between CHIP and outcome (mortality, urgent heart transplant, HF hospitalization and need for urgent visit due to HF decompensation) | At baseline; 1 year follow-up. | Obtained by medical health records |
| Association between CHIP and patients' clinical characteristics at baseline | At baseline; 1 year follow-up. | Obtained by medical health records |
Countries
Italy
Contacts
CONTACTAntonello Gavazzi, MD
CONTACTFENILI
STUDY_DIRECTORANTONELLO GAVAZZI, MD
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Outcome results
None listed