跳至主要内容
临床试验/NCT05343091
NCT05343091Unknown不适用

Prognostic Value of the Evaluation of Right Ventricular Function by Portable Ultrasound in Patients With Pulmonary Hypertension.

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
62
试验地点
1
主要终点
morbidity events with TAPSE

研究概览

简要总结

Pulmonary arterial hypertension (PAH) is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries, progressively generating an increase in pulmonary vascular resistance, right heart failure, and death. Current guidelines recommend a multidimensional approach which includes clinical, echocardiographic, exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions.

There is a wide range of studies, which have shown a good correlation between standard echocardiography and portable cardiac ultrasound. There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit, emergency department and even during hospital rounds; however, its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration, such as patients with PAH, has not yet been demonstrated.

There is evidence that a TAPSE measurement <17mm using standard echocardiography by a physician experienced in echocardiography predicts survival in patients with Pulmonary hypertension. We would like to know if patients with low TAPSE will have a higher proportion of morbidity events compared to patients with normal TAPSE measured by portable ultrasound.

详细描述

Pulmonary arterial hypertension (PAH) is a disease characterized by obliteration and remodeling of small-caliber pulmonary arteries, progressively generating an increase in pulmonary vascular resistance, right heart failure, and death. Current guidelines recommend a multidimensional approach which includes clinical, echocardiographic, exercise and hemodynamic variables to classify patients by risk and thus define a prognosis and guide therapeutic decisions.

Transthoracic Echocardiography (TTE) currently plays an important role in the diagnostic algorithm of PAH as it is minimally invasive and readily available. Moreover, many echocardiographic parameters are closely related to pulmonary hemodynamics. Some TTE parameters are associated with mortality and surviving in these patients, such as: shortening fraction, presence of pericardial effusion, eccentricity index, systolic displacement of the tricuspid annular plane (TAPSE), size of the right atrium and right ventricular free wall strain.

Ultrasound (US) is the only method which enables realtime bedside imaging of the heart. Focused cardiac US provides worthy diagnostic information useful for the the clinical management of critical care patients. The use of cardiac ultrasound in the last decade has gradually increased among non cardiologists. Pocket ultrasounds are part of the third generation of ultrasounds described in the literature. These have the characteristic of being light devices weighing less than 1kg and that can be carried in the pocket of the medical uniform. This leads many researchers to believe that in the not too distant future its use will be part of the physical examination routine, as the stethoscope is now.

There is a wide range of studies, which have shown a good correlation between standard echocardiography and portable cardiac ultrasound. There is no doubt about the usefulness of portable cardiac ultrasound in the intensive care unit, emergency department and even during hospital rounds; however, its usefulness during the daily examination in a follow-up consultation of patients at high risk of cardiovascular deterioration, such as patients with PAH, has not yet been demonstrated.

STATEMENT OF THE PROBLEM Does the measurement of tricuspid annular plane systolic displacement (TAPSE) by portable cardiac ultrasound have prognostic utility in the follow-up of patients with Pulmonary Hypertension?

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

入选标准

  • Patients with the diagnosis of Pulmonary Hypertension group 1 and 4 by right heart catheterization.
  • Presence of a baseline transthoracic echocardiogram as well as a follow-up echocardiogram.
  • Presence of 6m baseline walk as well as follow-up.

排除标准

  • All patients with left heart disease associated with PH
  • All patients with pulmonary disease associated with PH
  • All patients with congenital heart disease who had poor surgical repair.
  • Patients who meet the contraindication by the American chest guidelines to perform the 6m walk test.

结局指标

主要结局

morbidity events with TAPSE

时间窗: 9 months

Estimate the risk of morbidity events, between patients with PH who have a low TAPSE and those with a normal TAPSE.

次要结局

  • right heart dysfunction(9 months)
  • other ultrasound parameters(9 months)

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Luis Hernandez Oropeza

PhD, Head of Cardiopneumology Department

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

研究点 (1)

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