Splanchnic Nerve Blockade in Chronic Heart Failure. Splanchnic CHF
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)
研究概览
简要总结
Patients with chronic heart failure and undergoing right heart catheterization will be enrolled in this study. Subjects will undergo catheterization of the heart to obtain central cardiac pressure and other cardiac hemodynamic parameters. Subsequently, the subject will undergo a regional nerve block of the splanchnic nerves.
This study will be a prospective, uncontrolled clinical trial. The study will not be controlled as invasive monitoring of hemodynamics will be performed, allowing clear demonstration of a cause-effect relationship. The goal of the study is to provide proof of concept.
Patients will undergo detailed physiological testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of heart failure (HF)
- •Symptomatic with dyspnea
- •On a stable HF drug regimen
排除标准
- •Ongoing treatment with oral anticoagulation other than aspirin
- •Immunosuppressive medications for solid organ transplant
- •Acute MI (STEMI or Type I NSTEMI) within 7 days
- •Systolic blood pressure < 90 mmHg or >180 mmHg
- •Infiltrative cardiomyopathy or constrictive cardiomyopathy
- •Chronic kidney disease stage 5
- •Pregnancy
研究组 & 干预措施
Regional nerve anesthesia
干预措施: splanchnic nerve anesthesia with a local anesthetic (Drug)
结局指标
主要结局
Exercise Capacity as Measured by Peak Oxygen Uptake (Peak VO2)
时间窗: baseline, up to 1 hour
Peak VO2 will be measured before and after nerve block.
Mean Pulmonary Arterial Pressure (mPAP)
时间窗: baseline, up to 1 hour
Mean pulmonary arterial pressure will be measured before and after nerve block.
Pulmonary Capillary Wedge Pressure (PCWP)
时间窗: baseline, up to 1 hour
Pulmonary capillary wedge pressure will be measured at 20 Watts steady state and peak exercise.
次要结局
- Cardiac Index (CI)(baseline, up to 1 hour)
- Urine Output(2 hours pre-SNB, 2 hours post-SNB)
- Renal Biomarker Levels(2 hours pre-SNB, 2 hours post-SNB)