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临床试验/NCT06692439
NCT06692439尚未招募不适用

Acute Heart Failure in Elderly Patients Admitted to the Emergency Department with Acute Dyspnea: a Multimarker Approach Prognostic Study

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 185 人开始时间: 2024年11月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
185
主要终点
Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients.

研究概览

简要总结

Background and Rationale:

Acute dyspnea is a frequent presenting symptom in emergency departments (ED), with acute heart failure (AHF) being the most common cause leading to hospitalization in elderly patients. AHF in this population presents unique challenges in diagnosis, management, and risk stratification. Current tools for severity assessment and risk stratification (NT-proBNP and echocardiography) have shown limited evolution over the past 20 years and remain insufficient, particularly for elderly patients who predominantly present with heart failure with preserved ejection fraction (HFpEF). Recent European Society of Cardiology (ESC) and American Heart Association (AHA) guidelines specifically call for research on biomarkers within a multi-marker strategy for AHF risk stratification.

Research Hypothesis:

The study hypothesizes that a combination of biomarkers (NT-proBNP, High-sensitivity Troponin I, ST2, Galectin-3, CD146 and suPAR) will provide prognostic value and effectively stratify risk for early outcomes (90-day mortality and hospital readmission) in patients aged ≥75 years presenting to the ED with acute dyspnea and diagnosed with AHF.

Primary Objective:

To evaluate the prognostic value of six biomarkers, both individually and in combination, for predicting 90-day all-cause mortality or ED readmission in elderly patients (≥75 years) presenting with acute dyspnea and diagnosed with AHF.

Study Design:

This is a prospective prognostic study including patients from 7 emergency departments from university and non-university hospitals in France.

Study Population:

(I) Patients aged ≥75 years presenting to the ED with acute dyspnea meeting at least two criteria:

  • Respiratory rate ≥25/min
  • PaO2 ≤70 mmHg
  • SpO2 ≤92% on room air
  • PaCO2 ≥45 mmHg and pH ≤7.35
  • Oxygen requirement

(ii) Have confirmed AHF diagnosis by two expert reviewers based on clinical data, laboratory results (excluding NT-proBNP), ECG, imaging, and specialized cardiac echo

Primary Endpoint:

Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients.

Analysis plan includes:

  • ROC curves for optimal biomarker thresholds
  • Kaplan-Meier survival analysis with log-rank tests
  • Univariate and multivariate Cox regression analyses
  • Bootstrap methods for confidence intervals

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
75 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥75 years from the READ cohort (NCT04240067) who:
  • Present to the ED with acute dyspnea meeting at least two criteria:
  • Respiratory rate ≥25/min
  • PaO2 ≤70 mmHg
  • SpO2 ≤92% on room air
  • PaCO2 ≥45 mmHg and pH ≤7.35
  • Oxygen requirement
  • Have confirmed AHF diagnosis by two expert reviewers based on clinical data, laboratory results (excluding NT-proBNP), ECG, imaging, and specialized cardiac echo
  • Provided written consent for data use in the READ-MA-PRONO study

排除标准

  • No written consent for data use in the READ-MA-PRONO study

结局指标

主要结局

Composite endpoint of 90-day all-cause mortality or ED readmission, as recommended by the ESC for evaluating early outcomes in AHF patients.

时间窗: 90-day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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