Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.

NCT06626685 | Recruiting DMC

• 1 other identifier: RICO-HF
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Outcome Measures

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.

  Obtained by medical health records

  At diagnosis during the baseline

Secondary Outcomes (5)

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

  At baseline; 1 year follow-up.

• Estimation of CHIP prevalence in HF patients, according to the acute or chronic conditions and classified by LVEF

  At baseline; 1 year follow-up.

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

  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)

  At baseline; 1 year follow-up.

• Association between CHIP and patients' clinical characteristics at baseline

  At baseline; 1 year follow-up.

Study Arms (2)

Acute Heart Failure

Patients hospitalized with acute HF classified according to LVEF.

Other: Clinical and instrumental examination

Chronic Heart Failure

Ambulatory patients with chronic HF classified according to LVEF.

Other: Clinical and instrumental examination

Interventions

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.

Acute Heart Failure; Chronic Heart Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS: lead

Study Sites (2)

ATS BERGAMO Agenzia di Tutela della Salute

Bergamo, 24121, Italy

ACTIVE NOT RECRUITING

Asst Papa Giovanni Xxiii - Dip. Di Cardiologia

Bergamo, 24127, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The study of clonal hematopoiesis requires the use of sequencing technologies, as the Next Generation Sequencing (NGS), currently employed in the diagnosis and therapy of solid tumors and hematological malignancies.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• ANTONELLO GAVAZZI, MD

  FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

  STUDY DIRECTOR

Central Study Contacts

Antonello Gavazzi, MD

CONTACT

+39 0352675134; agavazzi@fondazionefrom.it

FENILI

CONTACT

sperimentazioni@fondazionefrom.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: March 10, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

IT (2)