Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.
- Conditions
- Heart Failure
- Interventions
- Other: Clinical and instrumental examination
- Registration Number
- NCT06626685
- Lead Sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acute Heart Failure Clinical and instrumental examination Patients hospitalized with acute HF classified according to LVEF. Chronic Heart Failure Clinical and instrumental examination Ambulatory patients with chronic HF classified according to LVEF.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
ATS BERGAMO Agenzia di Tutela della Salute
🇮🇹Bergamo, Italy
Asst Papa Giovanni Xxiii - Dip. Di Cardiologia
🇮🇹Bergamo, Italy