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Acupuncture in Cardiovascular Disease

Primary Purpose

Congestive Heart Failure

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Acupuncture, Heart Failure, Autonomic nervous system

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Chronic congestive heart failure class II-III No unstable angina No myocardial infarction within 3 months No peripheral neuropathy

Sites / Locations

  • UCLA School of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 20, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00032422
Brief Title
Acupuncture in Cardiovascular Disease
Official Title
Acupuncture in Cardiovascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if acupuncture decreases adrenaline levels in heart failure, thereby potentially improving survival and quality of life.
Detailed Description
Acupuncture is used to lower blood pressure in patients with hypertension, and to relieve angina in patients with coronary artery disease. While the biological mechanisms of acupuncture analgesia have been studied intensely in animals and humans, the biological mechanisms for modulation of the cardiovascular system in humans remain largely unexplored. Acupuncture at traditional acupoints, and at nonacupoints, decreases the blood pressure response during mental stress in normal humans. This depressor effect cannot be fully explained by a decline in muscle sympathetic nerve activity (MSNA). Further, in humans with heart failure (HF) in whom MSNA is elevated, we have preliminary data that acupuncture significantly decreases the MSNA response during mental stress. The following hypotheses will be tested: 1) acupuncture, performed at traditional acupoints and non-acupoints in normal humans, stimulates skeletal muscle afferent neurons causing a release of endogenous opioids, which oppose sympathetic excitation and vasoconstriction in visceral vascular beds, such as the kidney; 2) in humans with HF in whom MSNA is elevated and renal vasoconstriction is the rule, acupuncture utilizes similar mechanisms as in normal humans to produce exaggerated inhibition of MSNA and reflex renal vasoconstriction. Positron emission tomography and microneurography will be utilized to answer the following questions in normal humans and patients with heart failure: 1. Is acupuncture attenuation of BP during mental stress mediated by a decrease in renal vasoconstriction? 2. Is acupuncture sympathoinhibitory? 3. Is acupuncture modulation of the autonomic nervous system mediated by muscle afferents? 4. Is acupuncture modulation of the autonomic nervous system mediated by activation of endogenous opioids? Understanding the mechanisms of acupuncture modulation of the autonomic nervous system in humans may help clarify its role as a therapeutic modality in cardiovascular diseases, such as heart failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Acupuncture, Heart Failure, Autonomic nervous system

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Acupuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Chronic congestive heart failure class II-III No unstable angina No myocardial infarction within 3 months No peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly R Middlekauff, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
KaKit Hui, MD
Organizational Affiliation
UCLA East/West Medical Center
Facility Information:
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1679
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11294769
Citation
Middlekauff HR, Yu JL, Hui K. Acupuncture effects on reflex responses to mental stress in humans. Am J Physiol Regul Integr Comp Physiol. 2001 May;280(5):R1462-8. doi: 10.1152/ajpregu.2001.280.5.R1462.
Results Reference
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Acupuncture in Cardiovascular Disease

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