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保存または軽度に低下した心機能を有する代償不全心不全で入院した患者集団における循環遺伝子またはタンパク質炎症性バイオマーカーと生体インピーダンスパラメータの記述的研究 (BIOFEVIP)

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

保存期または軽度低下した駆出率を伴う心不全で入院した患者の炎症プロファイルと、予後価値を持つバイオインピーダンスパラメータおよびその他のバイオマーカーとの相関

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

観察的

入学 (推定)

112

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • スペイン
    • Madrid
      • Madrid、Madrid、スペイン、28040
        • 募集
        • Hospital Fundacion Jimenez Diaz
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Description of circulating inflammatory gene or protein biomarkers and other biomarkers with prognostic value in a population of patients hospitalized for acute HF.
時間枠：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.
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
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.
時間枠：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.
時間枠：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.
時間枠：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
時間枠：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.
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月12日

一次修了 (推定)

2028年1月1日

研究の完了 (推定)

2028年1月1日

試験登録日

最初に提出

2025年12月8日

QC基準を満たした最初の提出物

2025年12月20日

最初の投稿 (実際)

2026年1月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月5日

QC基準を満たした最後の更新が送信されました

2026年11月4日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PIC011-25_FJD

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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