Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
chronic therapy with anti-inflammatories, steroids, immunomodulators, immunosuppressants, chemotherapeuthic agents
previous heart transplant
cardiogenic shock or cardiac arrest
recent acute coronary syndrome (<3 months)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Clinical and instrumental examination
Other interventionEach 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Acute Heart Failure1 intervention
Group B: Chronic Heart Failure1 intervention
Trial outcomes
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
Time frame
At diagnosis during the baselineSecondary outcomes
1
Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions
Obtained by medical health records
Time frame
At baseline; 1 year follow-up.2
Estimation of CHIP prevalence in HF patients, according to the acute or chronic conditions and classified by LVEF
Obtained by medical health records
Time frame
At baseline; 1 year follow-up.3
Association between CHIP and patterns of inflammatory biomarkers in patients with acute de novo HFpEF
Obtained by medical health records
Time frame
At baseline; 1 year follow-up.4
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
Time frame
At baseline; 1 year follow-up.Sponsors and contacts
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Source ClinicalTrials.gov