Clonal Hematopoiesis of Indeterminate Potential in Heart Failure - RICO-HF.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: At diagnosis during the baseline
Obtained by medical health records
次要结局
- 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.)