Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Blood Pressure
研究概览
简要总结
Acupuncture is believed to increase blood pressure in people who struggle with low blood pressure. This is a common problem facing people with heart failure, and sometimes these people need to take medications to artificially increase their blood pressure. This study is designed to determine if using acupuncture in people with heart failure can improve their blood pressure enough to not require medications to artificially increase blood pressure.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patient receives true or sham acupuncture, and patient is unaware of treatment assignment. Acupuncturist is aware of treatment assignment, as is the statistician who is aware of randomization assignment but not involved otherwise in the execution of clinical trial. Investigators, medical assistants, and patients' physicians are unaware of treatment assignment.
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
- •Age greater than or equal to 18 years old
- •Chronic congestive heart failure (systolic or diastolic)
- •Medication list includes midodrine or fludrocortisone, either taking as scheduled or as needed
排除标准
- •History of acupuncture of any kind in the last 3 months
- •Acute decompensated heart failure, as indicated by clinical picture at time of enrollment
- •Currently on a mechanical device (LVAD, TAH, ECMO)
- •History of hepatorenal syndrome, adrenal insufficiency, for which midodrine and fludrocortisone respectively is specifically being used to treat that condition
- •Lack of suitable locations for which to place acupuncture seeds
结局指标
主要结局
Blood Pressure
时间窗: 9 weeks
Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position
次要结局
- NYHA Class(Start, 5 weeks, and 9 weeks)
- Quality of Life Score(Start, 5 weeks, and 9 weeks)
- Medication Dose Change(9 weeks)
- Composite Safety Outcome(Throughout study, total time 9 weeks)
- Standing Blood Pressure adjusted for Medication(9 weeks)
- Got off medications(9 weeks)
- Blood Pressure adjusted for Medication(9 weeks)