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临床试验/NCT05665218
NCT05665218招募中不适用

Cardiac Output Assessment in Pulmonary Hypertension Patients Undergoing Right Heart Catheterization

UOSD Emodinamica Diagnostica e Interventistica1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1
试验地点
1
主要终点
differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)

研究概览

简要总结

The objective of this observational study is to compare cardiac output evaluation by the Direct Fick method, Indirect Fick method and Thermodiluition in pulmonary hypertension (PH) patients undergoing right heart catheterization (RHC).

The main questions it aims to answer are:

  • Are these methods interchangeable?
  • Can possible discrepancies influence risk stratification and therapeutic management of PH patients? All consecutive patients aged ≥18 years, referred for RHC for suspected PH, will be included. Exclusion criteria will be contraindications to RHC, cardiac shunts and failure to obtain informed consent. Patients will undergo RHC by a Swan-Ganz catheter through the right internal jugular vein ultrasound-guided cannulation and cardiac output will be calculated using the three above-mentioned methods.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Age ≥18 years
  • Suspected pulmonary hypertension at clinical and echocardiographic evaluation

排除标准

  • contraindication to Right Heart Catheterization (RHC)
  • cardiac shunt
  • inability to provide informed consent

结局指标

主要结局

differences in cardiac output values measured using three different methods (Direct Fick, Indirect Fick and Thermodiluition)

时间窗: through study completion, an average of 1 year

In all patients cardiac output will be measured using the three methods to evaluate if the values obtained significantly differ

次要结局

未报告次要终点

研究者

发起方
UOSD Emodinamica Diagnostica e Interventistica
申办方类型
Other
责任方
Principal Investigator
主要研究者

Livio Giuliani

Livio Giuliani MD, PhD

UOSD Emodinamica Diagnostica e Interventistica

研究点 (1)

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