CTRI/2012/05/002681招募中未知
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study - (ANTHEM-HF)
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients enrolled in the study must meet all of the following criteria:
- •1. Age 18 or above
- •2. Willing and capable of providing informed consent
- •3. Capable of participating in all testing associated with this clinical investigation
- •4. Prescribed to optimal pharmacologic therapy for at least 1 month and stable beta blocker therapy for at least 3 months
- •5. Stable symptomatic heart failure NYHA class II/III
- •6. Left ventricular ejection fraction (EF) <= 40%
- •7. Left ventricular end diastolic diameter (LVEDD) >= 50 mm and < 80 mm
- •8. QRS width < 130 ms
- •9. 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:
- •1. Patients who have been hospitalized for heart failure and who required the use of HF IV therapy in the past 30 days
- •2. Patients unable to tolerate anesthesia required for implant
- •3. Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack in the past 90 days
- •4. Patients with chronic atrial fibrillation (lasting more than 1 week or requiring cardioversion or pharmacologic conversion) in the past 180 days.
- •5. 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
- •6. Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification
- •7. Patients with cardiac pacemakers, and pacemaker indicated patients
- •8. Patients whose heart failure is due to congenital heart disease
- •9. Patients who are on an organ transplant list or expected to have an organ transplant within 6 months
- •10. Patients who have received inotropic therapy in the past 60 days11. Patients who have had amiodarone therapy initiated in the past 60 days with a maintenance dose of over 200 mg daily
- •12. Patients actively treated for sleep apnea or sleep disordered breathing with therapies to maintain airway patency with or without oxygen supplementation
- •13. Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
- •14. Patients on or indicated for renal dialysis
- •15. 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.
- •16. Patients with hypotension (systolic blood pressure below 80 mmHg)
- •17. Patient with active peptic ulcer disease or history of upper GI bleeding, or ulcer within 6 months
- •18. Patients with asthma, history of severe COPD (e.g., FEV1 1.5 L) severe restrictive lung disease or oxygen dependence.
- •19. 1st degree AV block with PR interval 240 msec, 2nd or 3rd degree AV block
- •20. Patients with a life expectancy of less than 12 months per physician judgment
- •21. Patients involved in any concurrent clinical investigation
- •22. Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding
- •23. Patients with a prior cardiac transplant
- •24. Patients with congenital or acquired long QT syndrome.
- •25. Patients with documented recorded or suspected vasovagal syncope or vasodepressor syncope.
- •26. Patients who have undergone treatment by an investigational drug or device in the past 90 days
- •27. Patients with a prior vagotomy
- •28. Patients with prior or existing vagal nerve stimulation treatment
- •29. Patients who have a cardiac resynchronization therapy (CRT) device, or are scheduled for CRT in the next 6 months
- •30. Patients with locally implanted semi/permanent devices such as vascular catheters, etc.
- •31. Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system
- •32. Patients with known recurrent nerve paralysis33. Patients with untreated hypothyroidism or hyperthyroidism
研究者
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