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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Clinical and instrumental examination

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: FENILI; Email: sperimentazioni@fondazionefrom.it
• Study Contact Backup: Name: Antonello Gavazzi, MD; Phone Number: +39 0352675134; Email: agavazzi@fondazionefrom.it

Study Locations

• Italy
  • Bergamo, Italy, 24121
    • Active, not recruiting
    • ATS BERGAMO Agenzia di Tutela della Salute
  • Bergamo, Italy, 24127
    • Recruiting
    • Asst Papa Giovanni Xxiii - Dip. Di Cardiologia
    • Contact: MICHELE SENNI, MD
    • Principal Investigator: MICHELE SENNI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Acute Heart Failure; Patients hospitalized with acute HF classified according to LVEF.	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.
Chronic Heart Failure; Ambulatory patients with chronic HF classified according to LVEF.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Obtained by medical health records	At diagnosis during the baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions	Obtained by medical health records	At baseline; 1 year follow-up.
Estimation of CHIP prevalence in HF patients, according to the acute or chronic conditions and classified by LVEF	Obtained by medical health records	At baseline; 1 year follow-up.
Association between CHIP and patterns of inflammatory biomarkers in patients with acute de novo HFpEF	Obtained by medical health records	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)	Obtained by medical health records	At baseline; 1 year follow-up.
Association between CHIP and patients' clinical characteristics at baseline	Obtained by medical health records	At baseline; 1 year follow-up.

Collaborators and Investigators

• Sponsor: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
• Investigators: Study Director: ANTONELLO GAVAZZI, MD, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: RICO-HF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No