Evaluation of the Effect of Neurostimulation in Patients With Symptomatic Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Markers of efficacy
研究概览
简要总结
The purpose of this study is to study the use of neurostimulation in chronic advanced refractory heart failure.
The study is determine if it is safe to use neurostimulation in patients with chronic advanced refractory heart failure and to also determine initial observations with regards to its potential effect on heart function and quality of life. The investigators hypothesis is that this study will show both safe and positive effect of neurostimulation on heart failure patients.
详细描述
Protocol Summary
Title EVALUATION OF THE SAFETY OF NEUROSTIMULATION IN PATIENTS WITH SYMPTOMATIC HEART FAILURE FEASIBILTIY STUDY
Description A feasibility trial of the use of neurostimulation in chronic advanced refractory heart failure.
Objective To determine the safety of neurostimulation in patients with chronic advanced refractory heart failure and to generate initial observations with regards to its potential effect on ventricular function and quality of life.
Design The trial will be a randomized double blind crossover feasibility trial with 2 week and 1,2,3,4,5,6,7 month clinical follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Neurostimulation + Medication management
Investigational nerve stimulator device implanted to heart plus standard medication therapy.
干预措施: Neurostimulation + Medication Management (Standard of Care) (Device)
Neurostimulation + Medication management
Investigational nerve stimulator device implanted to heart plus standard medication therapy.
干预措施: Standard of Care (Control) (Drug)
Standard of Care (Control)
Standard of Care treatment is medication management only. Heart failure medications control symptoms and comorbidities, i.e. blood thinners, lipid lowering, and diuretics, and manage heart function, i.e. heart rhythm, rate, and pumping strength.
干预措施: Standard of Care (Control) (Drug)
结局指标
主要结局
Markers of efficacy
时间窗: Average: till the end of the study
Markers of efficacy will include change in left ventricular ejection fraction as determined by echocardiography, change in maximal oxygen consumption as measured by cardio-pulmonary exercise testing, and change in quality of life as measured by the MLHFQ. Other exploratory markers include measurements in diastolic function by echocardiography, changes in neurohormonal and inflammatory markers, specifically BNP, plasma cytokines(TNF alpha and IL 6), complement, and C-reactive protein.
Markers of cardiovascular safety
时间窗: 2 years
Markers of cardiovascular safety will include specific clinical events that define worsening of heart failure including hospitalization for worsening heart failure, symptomatic brady-arrhythmia or tachy-arrhythmia necessitating cardioversion or death.
Markers of device-device interaction
时间窗: 2 years
Markers of device-device interaction will include failure to properly provide pacing or adequate defibrillation or inappropriate shocks. Also, failure to initiate neurostimluation as programmed by the protocol
次要结局
未报告次要终点
研究者
Jerry Estep, MD
Sponsor-Investigator/Principal Investigator
The Methodist Hospital Research Institute