此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

对因心功能保留或轻度降低的失代偿性心力衰竭住院患者群体中循环基因或蛋白炎症生物标志物与生物阻抗参数的描述性研究 (BIOFEVIP)

2026年11月4日 更新者：Ana María Venegas Rodriguez、Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

因射血分数保留或轻度降低心力衰竭住院患者的炎症特征及其与生物阻抗参数和其他具有预后价值的生物标志物的相关性

The goal of this observational study is to determine whether changes in the inflammatory profile of heart failure patients can help identify those who may have a worse prognosis or who might benefit more from specific treatments. In addition, we aim to explore whether certain genes or gene mutations are related to a higher risk of future cardiovascular problems.

Heart failure continues to be a major cause of hospital admissions and death in our society. Because of this, it is very important for healthcare professionals to identify which patients are at higher risk of complications, so that we can provide the best possible treatment and follow-up. One method we use to help predict how the disease may evolve is the study of biomarkers, which are measurable biological substances that can help detect, monitor, or treat illnesses in a more personalized way.

In this study, the investigators will measure mainly inflammatory biomarkers that will be analyzed from a blood sample taken during hospital stay after being diagnosed with heart failure with preserved or mildly reduced ejection fraction. Any important health events that happen during the next six months after patients are discharged from hospital will also be recorded.

In addition, it is known that more than 2,000 diseases are known to be caused by changes in specific genes. In the case of cardiomyopathies-heart muscle diseases that can lead to heart failure-genetic causes vary depending on the type, and studies suggest that between 10% and 50% of cases may have a genetic origin. Identifying genetic markers linked to heart failure with preserved or mildly reduced ejection fraction may help improve prevention, treatment, and risk assessment, as some genetic changes may be associated with repeated cardiovascular events. By studying not only circulating biomarkers but also genetic factors, the investigators hope to better understand whether certain gene alterations may increase a person's tendency to experience additional heart-related events.

This is an observational study, which means that medical care and treatment will be exactly the same whether patients choose to participate or not. Participation involves allowing researchers to collect relevant information from medical records and agreeing to the collection of two or three small additional blood samples for research purposes. These samples will be used to measure the biomarkers and to analyze genes in the white blood cell fraction obtained from the same tubes.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

112

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 西班牙
    • Madrid
      • Madrid、Madrid、西班牙、28040
        • 招聘中
        • Hospital Fundacion Jimenez Diaz
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All patients hospitalized for HF at the FundaciJiménez Díaz University Hospital (Madrid), with preserved or slightly reduced LV ejection fraction (LVEF ≥40%), with evidence of structural heart disease (left atrial dilation or left ventricular hypertrophy) and elevated natriuretic peptides.

描述

Inclusion Criteria:

  • Age ≥18 years at recruitment.

  • Signed informed consent.

  • Hospitalization due to decompensated heart failure, based on Framingham criteria and elevated natriuretic peptides (N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) ≥450 pg/ml, or ≥900 pg/ml for patients with atrial fibrillation or flutter).

  • Left ventricular ejection fraction(LVEF) ≥40% and evidence of structural heart disease based on the presence of at least one of the following imaging criteria:

    • Left atrial dilation: LA diameter ≥3.8 cm, or area ≥20 cm², or LA volume ≥55 ml, or indexed LA volume ≥29 ml/m².
    • Left ventricular hypertrophy, defined as septal or posterior wall thickness ≥1.1 cm.
    • Evidence of increased filling pressures, measured by septal or lateral E/e' ratio >15 or >12, respectively.

Exclusion Criteria:

  • Hemodynamic instability at the time of inclusion.

  • Heart failure secondary to acute myocardial infarction (AMI).

  • Pregnant or breastfeeding women.

  • Comorbidities that could influence the clinical course:

    • COPD requiring long-term home oxygen therapy, oral corticosteroids, hospitalization due to exacerbation, or primary pulmonary arterial hypertension.
    • Chronic treatment with immunosuppressants, corticosteroids, or IL-1 antagonists within the 6 months prior to inclusion.
    • Confirmed active infection or patients currently receiving antibiotic treatment.
    • Acute or chronic liver disease.
    • Chronic kidney disease with eGFR <15 ml/min/1.73 m² or need for dialysis during hospitalization.
    • Hematological disorders, such as blood dyscrasias or hemoglobin <9 g/dl on admission.
    • Active oncological disease, except treated basal cell carcinoma or low-risk prostate cancer.
    • Patients with limb amputation or carriers of pacemakers or defibrillators (due to possible errors in BIA measurements).
    • Any disease associated with a life expectancy of less than one year, or patients expected to have difficulty adhering to the study protocol

  • Patients actively participating in other clinical trials involving investigational drugs at the time of inclusion.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Description of circulating inflammatory gene or protein biomarkers and other biomarkers with prognostic value in a population of patients hospitalized for acute HF.
大体时间：At enrollment

Biomarkers with prognostic value in heart failure such as troponins, natriuretic peptides or CA-125, biomarkers of mineral metabolism and inflammatory or profibrotic biomarkers including C- reactive protein, tumoral necrosis factor-α, interleukins, galectin-3, MCP-1, pentraxin-3 or myeloperoxidase, will be measured at admission in a population of patients hospitalized for decompensated heart failure with preserved or mildly reduced left ventricular ejection fraction.
At enrollment
Description of parameters obtained by bioimpedance analysis (BIA) in a population of patients hospitalized for decompensated HF with preserved or mildly reduced ejection fraction.
大体时间：At enrollment

Description of parameters obtained by bioimpedance analysis, including the assessment of body composition, hydration status and nutritional status in a population of patients hospitalized for decompensated HF with preserved or mildly reduced ejection fraction.
At enrollment

次要结果测量

结果测量
措施说明
大体时间
Incidence of major cardiovascular events in a population of patients hospitalized for decompensated HF with preserved or mildly reduced LV ejection fraction and its correlation with the inflammatory status.
大体时间：From inclusion to 6 months after discharge

Description of the incidence of all-cause mortality, cardiovascular mortality, heart failure hospitalization or Emergency-Department visit requiring intravenous diuretics in the first 6 months after discharge in a population of patients hospitalized for decompensated HF with preserved or mildly reduced LV ejection fraction and its correlation with the inflammatory status.
From inclusion to 6 months after discharge
Prognostic correlation of inflammatory biomarkers with the parameters obtained by bioimpedance analysis.
大体时间：At enrollment

To evaluate the prognostic correlation of inflammatory biomarkers measured in patients hospitalized for decompensated HF with preserved or mildly reduced LV ejection fraction with the parameters obtained by bioimpedance analysis performed at the time of inclusion, including both hydration and nutritional status.
At enrollment
Correlation of inflammatory biomarkers with other circulating biomarkers with prognostic value in HF.
大体时间：At enrollment

To study the correlation of the inflammatory profile alterations with other biomarkers with prognostic value in HF such as natriuretic peptides and fibrosis or mineral metabolism biomarkers.
At enrollment
Correlation of inflammatory biomarkers with echocardiographic data with prognostic value
大体时间：At enrollment

To examine the correlation of inflammatory biomarkers with echocardiographic study at enrollment, including left ventricular ejection fraction (LVEF), valvular heart disease, left ventricular end-diastolic diameter, myocardial wall thickness, left ventricular mass, parameters of left atrial dilation, right ventricular size and function, and parameters related to diastolic function.
At enrollment
Identification of different patient subgroups according to prognosis based on the inflammatory study.
大体时间：From inclusion to 6 months after discharge

To describe patient subgroups with different prognosis according to the etiology of heart failure or its associated comorbiditiesbased on the alterations identified in the inflammatory study.
From inclusion to 6 months after discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月12日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年1月1日

研究注册日期

首次提交

2025年12月8日

首先提交符合 QC 标准的

2025年12月20日

首次发布 (实际的)

2026年1月6日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • PIC011-25_FJD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅