Clonal Hematopoiesis of Indeterminate Potential in Heart Failure.

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• 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. [Срок оценки: At diagnosis during the baseline]

Вторичные конечные точки (5)

• Estimation of CHIP prevalence in patients with acute HFpEF, by de novo and worsening conditions [Срок оценки: At baseline; 1 year follow-up.]
• Estimation of CHIP prevalence in HF patients, according to the acute or chronic conditions and classified by LVEF [Срок оценки: At baseline; 1 year follow-up.]
• Association between CHIP and patterns of inflammatory biomarkers in patients with acute de novo HFpEF [Срок оценки: 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) [Срок оценки: At baseline; 1 year follow-up.]
• Association between CHIP and patients' clinical characteristics at baseline [Срок оценки: At baseline; 1 year follow-up.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 2 центра

• ATS BERGAMO Agenzia di Tutela della Salute — Bergamo
• Asst Papa Giovanni Xxiii - Dip. Di Cardiologia — Bergamo

Идентификаторы

NCT: NCT06626685 · RICO-HF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗