Heart FailureRICO-HFNCT06626685
Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.
An observational study of Heart Failure, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Clinical and instrumental examination
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 10 Mar 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- primary myelodysplastic syndromes
- malignant cancers
- non-cardiovascular co-morbidity reducing life expectancy to < 1 year
- any factor precluding 1-year follow-up
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
FENILI contact
Italy2 sites, 1 recruiting
- Active, not recruiting
ATS BERGAMO Agenzia di Tutela della Salute
Bergamo, 24121
- Recruiting
Asst Papa Giovanni Xxiii - Dip. Di Cardiologia
Bergamo, 24127
MICHELE SENNI, MD
MICHELE SENNI, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Clinical and instrumental examination
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and instrumental examinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acute Heart Failure | Patients hospitalized with acute HF classified according to LVEF. Receives: Other: Clinical and instrumental examination | |
| Chronic Heart Failure | Ambulatory patients with chronic HF classified according to LVEF. Receives: Other: Clinical and instrumental examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At diagnosis during the baseline
Secondary outcomes (5)
Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions
Obtained by medical health records
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline; 1 year follow-up.
Association between CHIP and patients' clinical characteristics at baseline
Obtained by medical health records
Measured: At baseline; 1 year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start10 Mar 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANTONELLO GAVAZZI, MD, Study director, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626685
- Sponsor's protocol ID
- RICO-HF
- Acronym
- RICO-HF
- Status last verified
- Jul 2026
- First submitted
- 2 Oct 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clonal Hematopoiesis of Indeterminate Potential in Heart Failure - RICO-HF.
- ClinicalTrials.gov ID
- NCT06626685
- Acronym / sponsor ID
- RICO-HF / RICO-HF
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Heart Failure | – | Other: Clinical and instrumental examinationPatients hospitalized with acute HF classified according to LVEF. |
| Chronic Heart Failure | – | Other: Clinical and instrumental examinationAmbulatory patients with chronic HF classified according to LVEF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and instrumental examinationEach 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. | Other | Acute Heart Failure, Chronic Heart Failure |
Primary outcome
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
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FENILI contact
ANTONELLO GAVAZZI, MD study director
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonello Gavazzi, MD (+39 0352675134, agavazzi@fondazionefrom.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At diagnosis during the baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.