跳至主要内容
临床试验/NCT05530512
NCT05530512招募中不适用

Neuroimmune Mechanisms Underlying Electroacupuncture Effect on Vascular Function

University of California, Irvine4 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
72
试验地点
4
主要终点
Changes in sympathetic and parasympathetic nervous systems

研究概览

简要总结

Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will be either on or off hypertensive medications. The course last for 8 weeks and the frequency is once a week.

详细描述

Improvement in BP control rates would lead to one of the largest impacts in improving life expectancy and the quality of life for over 100 million people in the United States and 1 billion people worldwide with immediate and measurable results. In the United States, 80% of patients with HTN are treated, but BP is controlled in only half of these individuals, with control worsening with increasing age. The reasons for inadequate treatment and BP control are complex, but one reason for this therapeutic misalignment may be an incomplete understanding of the mechanisms underlying the development and progression of HTN. The aging process leads to dysfunction of the ANS, resulting in neuroendocrine abnormalities and chronic low-grade inflammation.

The investigators have previously shown that electroacupuncture (EA) at four targeted acupoints, can decrease sympathetic activity [sympathoinhibitory (SI)], approaching levels close to those present prior to onset of HTN and may address this unmet need in HTN management. The investigators are now testing and have preliminary evidence that EA at two additional acupoints (SP6-7) increases parasympathetic activation, thereby decreasing circulating and tissue inflammatory biomarkers [thus anti-inflammatory (AI)] and when combined with SI-EA can improve measures of vascular health including endothelial function and arterial stiffness in preclinical model with overall greater reduction in BP. Together these combined six acupoints, when simultaneously activated by EA may restore optimal autonomic control of the immune system and target an important mechanistic pathway not addressed by BP-lowering pharmacotherapy alone. To date, 39 participants have been enrolled in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The pharmacologist who assays the plasma and serum is masked in the study.

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects from 45 to 75 years of age
  • Clinically diagnosed with mild to moderate hypertension and ON or OFF medication (Office SBP > 140 mmHg and < 160 mmHg Or ABPM average SBP > 130 mmHg and < 145 mmHg), and
  • No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.

排除标准

  • Subjects will be excluded if pregnant or nursing.
  • Subjects will be excluded if they have coronary disease (by history or on ECG screening), conduction abnormalities on ECG consistent with left bundle branch block, cardiac arrhythmias associated with low blood pressure (<90 mmHg), peripheral vascular disease, orthopedic disease, diabetic neuropathy or severe hypertension (BP >170 mmHg systolic or >110 mmHg diastolic), or any other physical or psychological illness.
  • Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.
  • Inability our or unwillingness of individual to give written informed consent.

结局指标

主要结局

Changes in sympathetic and parasympathetic nervous systems

时间窗: through study completion, an average of 4.5 years

Heart rate variability and its component will be evaluated with EKG.

次要结局

  • Change in biomarkers like cytokines(through study completion, an average of 4.5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shaista Malik

Professor

University of California, Irvine

研究点 (4)

Loading locations...

相似试验