Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical and instrumental examination.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clonal Hematopoiesis of Indeterminate Potential in Heart Failure - RICO-HF.
Overview
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
- Other 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.
Primary outcome measures
- 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. [Time frame: At diagnosis during the baseline]
Secondary outcome measures (5)
- Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions [Time frame: At baseline; 1 year follow-up.]
- Estimation of CHIP prevalence in HF patients, according to the acute or chronic conditions and classified by LVEF [Time frame: At baseline; 1 year follow-up.]
- Association between CHIP and patterns of inflammatory biomarkers in patients with acute de novo HFpEF [Time frame: 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) [Time frame: At baseline; 1 year follow-up.]
- Association between CHIP and patients' clinical characteristics at baseline [Time frame: At baseline; 1 year follow-up.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 2 centers
- ATS BERGAMO Agenzia di Tutela della Salute — Bergamo
- Asst Papa Giovanni Xxiii - Dip. Di Cardiologia — Bergamo
Identifiers
NCT: NCT06626685 · RICO-HF