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临床试验/NCT04792879
NCT04792879已完成不适用

Assessment of Peripheral Veins Doppler Ultrasound for Diagnosis of Acute Right Heart Failure in Suspicion or Follow-up of Pulmonary Hypertension

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2021年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
103
试验地点
1
主要终点
Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index

研究概览

简要总结

Occurrence of acute right heart failure (ARHF) remains common during pulmonary hypertension (PH). Right atrial pressure (RAP) invasive measurement is the gold standard to diagnose ARHF in order to improve diuretic treatment management. Existence of indirect signs of ARHF on venous Doppler ultrasound waveform has long been described, but correlation with RAP has not been properly established yet. It is the aim of our study in order to obtain an additional tool to manage ARHF.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient (age ≥ 18 years old)
  • Patient referred to the cardiology department for a right heart catheterization with measurement of RAP, regardless of the indication.
  • Free subject, without guardianship or curatorship or subordination
  • People affiliated to or beneficiary of a social security schemes
  • Informed consent signed by the patient after clear and fair information about the study.

排除标准

  • Minor patient (age < 18 years)
  • Refusal to participate in the study
  • Patient with hemodynamic instability, unable to tolerate a delay in treatment caused by the ultrasound examination.
  • Patient requiring diuretic treatment within the next 4 hours
  • Patient with a life expectancy of less than 24 hours.
  • History of proximal deep venous thrombosis involving the inferior vena cava and/or common iliac veins and/or femoral veins.
  • History of extrinsic venous compression on the inferior vena cava and/or common iliac veins and/or femoral veins.
  • Persons who do not benefit from a Social Security scheme or who do not benefit from it through a third party.
  • Persons benefiting from reinforced protection, namely minors, pregnant and nursing women, persons deprived of liberty by a judicial or administrative decision, persons staying in health or social institutions, adults under legal protection and finally patients in emergency situations.

结局指标

主要结局

Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index

时间窗: Inclusion day within 4 hours before the right heart catheterization

Sensitivity, specificity, positive and negative likelihood ratios of venous stasis index\*, measured by Pulsed Doppler on common femoral veins, as a diagnostic criterion for ARHF (defined by RAP ≥10 mm Hg). \* Defined as duration of non-anterograde venous flow during 3 seconds/ 3 seconds

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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