CTRI/2012/05/002681招募中不适用
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 11
- 主要终点
- The primary safety endpoint will be the incidence of procedure and device-related complications.
研究概览
简要总结
Patients with symptomatic heart failure will undergo 6 months of Intermittent therapeutic vagus nerve stimulation.
Study Hypothesis: To improve cardiac functions and reduce symptom expressions
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients enrolled in the study must meet all of the following criteria:
- •Age 18 or above
- •Willing and capable of providing informed consent
- •Capable of participating in all testing associated with this clinical investigation
- •Prescribed to optimal pharmacologic therapy for at least 1 month and stable beta blocker therapy for at least 3 months
- •Left ventricular ejection fraction (EF) ≤ 40%
- •Left ventricular end diastolic diameter (LVEDD) ≥ 50 mm and < 80 mm
- •QRS width < 130 ms
- •Physically capable and willing to perform repeated 6-minute walk tests associated with the study, and a baseline distance of between 150 and 425 meters.
- •Symptoms limiting the duration of the 6 minute walk test must be due to heart failure alone.
排除标准
- •Patients who meet any of the following criteria are not eligible to be enrolled in the study:
- •Patients who have been hospitalized for heart failure and who required the use of HF IV therapy in the past 30 days
- •Patients unable to tolerate anesthesia required for implant
- •Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack in the past 90 days
- •Patients with chronic atrial fibrillation (lasting more than 1 week or requiring cardioversion or pharmacologic conversion) in the past 180 days.
- •Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or PCI) in the past 90 days or anticipated in the next 180 days
- •Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
- •Patients with cardiac pacemakers, and pacemaker indicated patients
- •Patients whose heart failure is due to congenital heart disease
- •Patients who are on an organ transplant list or expected to have an organ transplant within 6 months
- •Patients who have received inotropic therapy in the past 60 days
- •Patients who have had amiodarone therapy initiated in the past 60 days with a maintenance dose of over 200 mg daily
- •Patients actively treated for sleep apnea or sleep disordered breathing with therapies to maintain airway patency with or without oxygen supplementation
- •Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- •Patients on or indicated for renal dialysis
- •Patients with diabetes (type I or type II) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin A1c (HbA1c) above 8.0% in the past 60 days.
- •Patient with active peptic ulcer disease or history of upper GI bleeding, or ulcer within 6 months
- •Patients with asthma, history of severe COPD (e.g., FEV1 1.5 L) severe restrictive lung disease or oxygen dependence.
- •1st degree AV block with PR interval 240 msec, 2nd or 3rd degree AV block
- •Patients with a life expectancy of less than 12 months per physician judgment
- •Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
- •Patients with a prior cardiac transplant
- •Patients with congenital or acquired long QT syndrome.
- •Patients with documented recorded or suspected vasovagal syncope or vasodepressor syncope.
- •Patients who have undergone treatment by an investigational drug or device in the past 90 days
- •Patients with a prior vagotomy
- •Patients with prior or existing vagal nerve stimulation treatment
- •Patients who have a cardiac resynchronization therapy (CRT) device, or are scheduled for CRT in the next 6 months
- •Patients with locally implanted semi/permanent devices such as vascular catheters, etc.
- •Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system
- •Patients with known recurrent nerve paralysis
- •Patients with untreated hypothyroidism or hyperthyroidism
- •Patients who have undergone radiotherapy for thyroid disease/cancer
- •Patients who have existing or prior tracheotomy
- •Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace
- •Patients who are likely to need shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy.
结局指标
主要结局
The primary safety endpoint will be the incidence of procedure and device-related complications.
时间窗: 6 months
The primary efficacy endpoint is ECHO assessment of left ventricular End systolic and diastolic volumes.
时间窗: 6 months
次要结局
- NYHA Class(1,3 and 6 months)
- Quality of Life questionnaire(3,6 months)
研究者
研究点 (11)
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