Clinical trial NCT06626685: Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.
Official title: Clonal Hematopoiesis of Indeterminate Potential in Heart Failure - RICO-HF.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Lead sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients consecutively afferent to the SC Cardiologia I of the ASST-PG23 Hospital in Bergamo with the diagnosis of acute or chronic Heart Failure.

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.

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

Primary outcomes:
measure: 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.
timeFrame: At diagnosis during the baseline
Secondary outcomes:
measure: Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions
timeFrame: At baseline; 1 year follow-up.
measure: Estimation of CHIP prevalence in HF patients, according to the acute or chronic conditions and classified by LVEF
timeFrame: At baseline; 1 year follow-up.
measure: Association between CHIP and patterns of inflammatory biomarkers in patients with acute de novo HFpEF
timeFrame: At baseline; 1 year follow-up.
measure: Association between CHIP and outcome (mortality, urgent heart transplant, HF hospitalization and need for urgent visit due to HF decompensation)
timeFrame: At baseline; 1 year follow-up.
measure: Association between CHIP and patients' clinical characteristics at baseline
timeFrame: At baseline; 1 year follow-up.
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ATS BERGAMO Agenzia di Tutela della Salute
city: Bergamo
country: Italy
facility: Asst Papa Giovanni Xxiii - Dip. Di Cardiologia
Study officials:
affiliation: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
name: ANTONELLO GAVAZZI, MD
role: STUDY_DIRECTOR
References: