Clinical trial NCT05530512: Acupuncture Therapy and Hypertension
Official title: Neuroimmune Mechanisms Underlying Electroacupuncture Effect on Vascular Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild to Moderate Hypertension
Keywords: hypertension, electroacupuncture
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: two by two factorial design for a 4 arm study.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subjects from 45 to 75 years of age
2. 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
3. No significant ECG change reflecting ischemia (i.e. ST elevation or depression) at rest will be recruited to participate in this study.

Exclusion Criteria:

1. Subjects will be excluded if on anti-hypertensive medications.
2. Subjects will be excluded if pregnant or nursing.
3. 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.
4. Those with known sensitivity to any topical preparations or strong reactions to medical dressings and skin tapes also will be excluded.
5. Inability our or unwillingness of individual to give written informed consent.

Primary outcomes:
measure: Changes in sympathetic and parasympathetic nervous systems
timeFrame: through study completion, an average of 4.5 years
Secondary outcomes:
measure: Change in biomarkers like cytokines
timeFrame: through study completion, an average of 4.5 years
Other outcomes:
measure: Change in blood pressure
timeFrame: through study completion, an average of 4.5 years
Locations:
city: Irvine
country: United States
facility: Susan Samueli Integrative Health Institute
state: California
city: Orange
country: United States
facility: University of California, Irvine, Health Sciences Medical Center
state: California
Study officials:
affiliation: University of California, Irvine
name: Shaista Malik
role: PRINCIPAL_INVESTIGATOR
References: