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NCT Number: NCT06626685

Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ATS BERGAMO Agenzia di Tutela della Salute, Bergamo, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

    Obtained by medical health records

Secondary outcomes

  1. Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions

    Time frame: At baseline; 1 year follow-up.

    Obtained by medical health records

  2. 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.

    Obtained by medical health records

  3. Association between CHIP and patterns of inflammatory biomarkers in patients with acute de novo HFpEF

    Time frame: At baseline; 1 year follow-up.

    Obtained by medical health records

  4. 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.

    Obtained by medical health records

  5. Association between CHIP and patients' clinical characteristics at baseline

    Time frame: At baseline; 1 year follow-up.

    Obtained by medical health records

Study contacts

Contact information is provided by the study sponsor or research team.

Antonello Gavazzi, MD

CONTACT

[email protected]

+39 0352675134

FENILI

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Official study title

Clonal Hematopoiesis of Indeterminate Potential in Heart Failure - RICO-HF.

Acronym: RICO-HF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 4, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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