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Acupuncture in Cardiovascular Disease

This study has been completed.
Study NCT00032422.   Last updated on August 17, 2006.   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  Acupuncture in Cardiovascular Disease
Official Title  Acupuncture in Cardiovascular Disease
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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Congestive Heart Failure
Intervention  Procedure: Acupuncture
MEDLINE PMIDs 11294769
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  200
Start Date  July 2001
Completion Date June 2003
Eligibility Criteria 
  • Chronic congestive heart failure class II-III
  • No unstable angina
  • No myocardial infarction within 3 months
  • No peripheral neuropathy
Gender Both
Ages 21 Years to 65 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00032422
Organization ID R21 AT000671-01
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Principal Investigator:     Holly R Middlekauff, MD     University of California, Los Angeles    
Investigator:     KaKit Hui, MD     UCLA East/West Medical Center    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date July 2006
First Received Date  March 20, 2002
Last Updated Date August 17, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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