Hemodynamic Effects of Transcutaneous Spinal Cord Stimulation in Patients With Chronic Heart Failure Undergoing Right Heart Catheterization for the Inclusion Into the Heart Transplantation Program: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Systolic blood pressure elevation
研究概览
简要总结
This is a prospective single-center study that aims to evaluate the effects of non-invasive transcutaneous spinal cord stimulation on systemic and pulmonary hemodynamics, assessed during right heart catheterization in patients with heart failure and persistent or transient hypotension subjected to be included into the heart transplantation waiting list.
详细描述
The study aims to assess hemodynamic effects of non-invasive transcutaneous spinal cord stimulation during invasive hemodynamics evaluation in patients with heart failure and transient or persistent hypotension undergoing catheterization before inclusion into the heart transplantation program. Eligible patients will sign an informed consent form before the procedure. Non-invasive transcutaneous electrical stimulation of the spinal cord will be applied using high-frequency modulated electrical impulses through adhesive electrodes attached to the back skin. The stimulation protocol includes analysis of the following parameters: heart rate; electrocardiogram in 12 leads; invasive blood pressure; pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac input, cardiac index, stroke volume, stroke volume index, systemic vascular resistance, pulmonary vascular resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years.
- •Patients with heart failure III-IV functional class (NYHA) with indications to right heart catheterization.
- •Systolic blood pressure <110/70 mm Hg when measured while sitting.
- •Patient who signed an informed consent form.
排除标准
- •Hypovolemic status (central venous pressure <2 mm Hg).
- •Any acute illness.
- •Transient ischemic event or stroke within 2 weeks prior to inclusion.
- •Pulmonary embolism <1 month ago.
- •An implanted infusion pump.
- •Pacemaker-dependent patients.
- •Patients who have contraindications to the use of the patch electrodes used in this study, as indicated in the respective instructions for use.
研究组 & 干预措施
Spinal cord stimulation in heart failure patients with hypotension
Adhesive patches are applied to subjects' back skin. Single stimuli are delivered in order to define the stimulation threshold under the guidance of neuromyography. Vascular access is performed (jugular or subclavian) according to conventional preparation to right heart catheterization. Invasive hemodynamic measures are performed as usual.
High-frequency spinal cord stimulation at T5 level is initiated, and repeated hemodynamic measures performed within 2 minutes. Stimulation lasts for 5-10 minutes, and then ceased. Following a 5-minutes waiting period, repeat hemodynamic measures are performed. The same sequence of steps applies for stimulation levels T7-8 and a combination of T5 and T7-8.
Then the procedure is completed and data are analysed.
干预措施: Spinal cord stimulation (Procedure)
结局指标
主要结局
Systolic blood pressure elevation
时间窗: 10 minutes
It is suggested that spinal cord stimulation will elevate averaged systolic blood pressure by \>5 mmHg within 10 minutes, as compared to tilt testing without stimulation, and as measured invasively through a vascular catheter. Number of participants with increase in systolic blood pressure by more than 5 mmHg within 10 minutes will be counted. The achievement of the primary outcome will be considered if \>50% of patients will have an increase in systolic blood pressure.
次要结局
- Pulmonary artery pressure change(10 minutes)
- Pulmonary capillary wedge pressure change(10 minutes)
- Systemic vascular resistance elevation(10 minutes)
- Pulmonary vascular resistance change(10 minutes)