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Acupuncture Therapy and Hypertension

Primary Purpose

Mild to Moderate Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electroacupuncture
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Mild to Moderate Hypertension

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects from 50 to 75 years of age
  2. Clinically diagnosed with mild to moderate hypertension and NOT on 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.

Sites / Locations

  • Susan Samueli Integrative Health InstituteRecruiting
  • University of California, Irvine, Health Sciences Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Anti-inflammatory EA (AI-EA)

Sympathoinhibitory EA (SI-EA)

Combined EA (cEA)

Control EA (Sham-EA)

Arm Description

Anti-inflammatory electroacupuncture therapy

sympatho-inhibitory electroacupuncture therapy

combination of SI-EA and AI-EA

Sham electroacupuncture

Outcomes

Primary Outcome Measures

Changes in sympathetic and parasympathetic nervous systems
Heart rate variability and its component will be evaluated with EKG.

Secondary Outcome Measures

Change in biomarkers like cytokines
Plasma will be measured for inflammatory markers with ELISA kits.

Full Information

First Posted
August 27, 2022
Last Updated
June 15, 2023
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT05530512
Brief Title
Acupuncture Therapy and Hypertension
Official Title
Acupuncture Therapy in Non Medicated Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acupuncture therapy will be provided to reduce blood pressure in hypertensive patients. The mild to moderate hypertensive patients will not be on 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 age1,2. 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, 12 participants have been enrolled in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate Hypertension

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
two by two factorial design for a 4 arm study.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti-inflammatory EA (AI-EA)
Arm Type
Experimental
Arm Description
Anti-inflammatory electroacupuncture therapy
Arm Title
Sympathoinhibitory EA (SI-EA)
Arm Type
Experimental
Arm Description
sympatho-inhibitory electroacupuncture therapy
Arm Title
Combined EA (cEA)
Arm Type
Experimental
Arm Description
combination of SI-EA and AI-EA
Arm Title
Control EA (Sham-EA)
Arm Type
Experimental
Arm Description
Sham electroacupuncture
Intervention Type
Other
Intervention Name(s)
electroacupuncture
Other Intervention Name(s)
acupuncture
Intervention Description
acupuncture needling and stimulation are applied for 30 min
Primary Outcome Measure Information:
Title
Changes in sympathetic and parasympathetic nervous systems
Description
Heart rate variability and its component will be evaluated with EKG.
Time Frame
through study completion, an average of 4.5 years
Secondary Outcome Measure Information:
Title
Change in biomarkers like cytokines
Description
Plasma will be measured for inflammatory markers with ELISA kits.
Time Frame
through study completion, an average of 4.5 years
Other Pre-specified Outcome Measures:
Title
Change in blood pressure
Description
Blood pressure (systolic and diastolic) will be measured with an ambulatory blood pressure device every 20 min for 24 hours.
Time Frame
through study completion, an average of 4.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects from 50 to 75 years of age Clinically diagnosed with mild to moderate hypertension and NOT on 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. Exclusion Criteria: Subjects will be excluded if on anti-hypertensive medications. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashwini Erande
Phone
7144567025
Email
aerande@hs.uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaista Malik
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Susan Samueli Integrative Health Institute
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Beasley, MD, PhD, MPH
Phone
949-824-7000
Email
beasleym@uci.edu
First Name & Middle Initial & Last Name & Degree
Shaista Malik, PhD
Phone
949-824-7000
Email
smalik@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
LiFang Xie, PhD, LAc
First Name & Middle Initial & Last Name & Degree
Shaista Malik, MD, PhD, MPH
First Name & Middle Initial & Last Name & Degree
Stephanie Tjen-A-Looi, PhD
Facility Name
University of California, Irvine, Health Sciences Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herlinda Bergman, M.Sc.
Phone
714-456-7090

12. IPD Sharing Statement

Plan to Share IPD
No

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Acupuncture Therapy and Hypertension

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