A Pilot Study of Spinal Cord Stimulation in Heart Failure Patients With Depressed Left Ventricular Function
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Dynamics of NT-pro-BNP-level
研究概览
简要总结
A randomized pilot study of spinal cord stimulation in patients with chronic heart failure aiming to show whether this therapy impacts central haemodynamic and autonomic regulations.
详细描述
Patients will be randomized (1:1) for spinal cord stimulation as an addition to optimal guidelines-driven management or to control group on optimal management only. Spinal cord stimulation will be performed for 30 days, and outcome measures will be testes before stimulation, after 30 days stimulation and after 30 days of further follow-up. The control group will be studied at baseline and after 30 days only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic heart failure II-III class (NYHA);
- •Age 18-70 years;
- •Left ventricle ejection fraction ≤35%;
- •Optimal heart failure management according to the guidelines;
- •Signed informed consent
排除标准
- •Heart transplant list;
- •Acute conditions, including systemic infection;
- •Reversible cause of heart failure (thyroid gland diseases, alcoholic intoxication etc);
- •Planned elective heart surgery or intervention;
- •Recent (3 months) myocardial infarction, coronary intervention;
- •Heart failure decompensation;
- •Implanted cardiac resynchronization device < 6 months ago;
- •Contraindications for lumbal puncture or placement of a spinal cord pacing electrode;
- •Permanent atrial fibrillation;
- •Stroke or TIA < 6 months ago;
- •Pulmonary thromboembolist < 3 months ago;
- •Hypertrophic cardiomyopathy with obstruction;
- •Angina III-IV class, or congestive heart failure IV class;
- •Participation in any other clinical trial;
- •Women of childbearing possibility without appropriate contraception, pregnant, or breastfeeding women.
结局指标
主要结局
Dynamics of NT-pro-BNP-level
时间窗: Baseline, 30, 60 days
NT-pro-BNP-level baseline, 30 days and 60 days (intervention) NT-pro-BNP-level baseline, 30 days (control)
次要结局
- Changes in heart failure functional class(Baseline, 30, 60 days)
- Exercise capacity as determined by a cardiopulmonary test(Baseline, 30, 60 days)
- Autonomic regulation tests results change(Baseline, 30, 60 days)
- Levels of pro-inflammatory plasma markers(Baseline, 30, 60 days)
- Number of participants with complications(Baseline, 30, 60 days)
- Changes in atrial effective refractory period(Baseline, 30, 60 days)
- Number of participants with ventricular arrhythmias(Baseline, 30, 60 days)
- Left ventricle volume(Baseline, 30, 60 days)
- Changes in left ventricle ejection fraction as determined by echocardiography(Baseline, 30, 60 days)