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临床试验/NCT05935865
NCT05935865招募中不适用

Monitoring of the Influence of Approved PH-therapies RV-PA Coupling

University of Giessen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Contractility

研究概览

简要总结

The goal of this observational study is to learn about the acute (days) changes in right ventricular functions caused by initiation of pharmacological therapies in patients with precapillary pulmonary hypertension. The main question it aims to answer is:

• Course of afterload and intrinsic contractility throughout the hospital stay Participants will be equipped with a device for continuous monitoring and recording of the right ventricular pressure signal.

详细描述

Pulmonary hypertension (PH) arises as a result of a vascular pathology affecting the pulmonary vessels, leading to an increase in resistance within the pulmonary circulation. The ability of the right ventricle to adapt to the elevated pressures caused by increased afterload is crucial for the progression and symptoms of the disease. This adaptation of the right ventricle to its afterload is referred to as ventriculoarterial coupling or RV-PA coupling, described by the ratio of contractility to afterload. Invasive pressure-volume loops (PV loops) are the gold standard for assessing RV-PA coupling. The loss of RV-PA coupling is considered a crucial factor in the development of right heart failure, the leading cause of mortality in patients with pulmonary hypertension. Therefore, reliable assessment of right cardiac function is essential for physicians to make informed decisions regarding further invasive diagnostics or therapy adjustments. Approved medications for the treatment of pulmonary arterial hypertension primarily induce pulmonary vasodilation, leading to a reduction in right ventricular afterload. The effects on right ventricular contractility and function, as represented by RV-PA coupling, are currently poorly understood and may not be consistent. In this study, 100 patients with PH requiring an inpatient stay for right heart catheterization will be equipped with a mobile, wireless system for invasive measurement of right ventricular pressure - the CorLog system (emka MEDICAL, Aschaffenburg, Germany). By combining continuously recorded pressure profiles with 3D echocardiographic volumetry, we will be able to generate PV loops and assess RV-PA coupling at various time points. The continuous monitoring of right ventricular pressure profiles throughout the entire hospital stay will allow us to capture the effects of newly initiated or expanded pulmonary vascular therapy on RV-PA coupling not only immediately but over several days. Furthermore, the 3D echocardiographic datasets will be analyzed using specialized software (ReVISION®, Argus Cognitive, Inc, Lebanon, NH) to mechanistically quantify the right ventricular contraction pattern and capture the immediate impact of pulmonary vasoreactive therapy on it. Additionally, a data pool will be created to validate the calculation of ejection fraction and RV-PA coupling based solely on pressure signals.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Initial diagnosis of PH (treatment-naive incident PH) of the Nice classifications 1 (PAH), 3 (PH related to lung diseases/hypoxia), and 4 (CTEPH), or known PH under ongoing vasoreactive therapy
  • No contraindications for right heart catheterization, conductance catheterization, or CorLog implantation
  • Written consent from the patient or their legal guardian

排除标准

  • Absence of written consent
  • Invasive exclusion of PH
  • Age < 18 years
  • Presence of contraindications for right heart catheterization, conductance catheterization, or CorLog implantation
  • Pregnancy or breastfeeding

结局指标

主要结局

Contractility

时间窗: 3-7days

Response of contractility (calculated from PV loops \[Ees\]) during hospitalization to the initiation or escalation of pulmonary vascular therapy

Coupling

时间窗: 3-7days

Response of Coupling (calculated from PV loops \[Ees/Ea\]) during hospitalization to the initiation or escalation of pulmonary vascular therapy

Validation of Echo/CorLog PV-Loops

时间窗: On first day

Validation of Echo/Corlog-generated PV loops based on conductance catheter-generated PV loops

Afterload

时间窗: 3-7days

Responce of afterload (calculated from PV loops \[Ea\]) afterload during hospitalization to the initiation or escalation of pulmonary vascular therapy

次要结局

  • Contraction patterns(3-7 days)
  • Validation of pressure-only methods(3-7days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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