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Acupuncture in Cardiovascular Disease

This study has been completed.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00032422
  Purpose

The purpose of this study is to determine if acupuncture decreases adrenaline levels in heart failure, thereby potentially improving survival and quality of life.


Condition Intervention Phase
Congestive Heart Failure
Procedure: Acupuncture
Phase II

MedlinePlus related topics:   Acupuncture    Heart Failure   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Acupuncture in Cardiovascular Disease

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment:   200
Study Start Date:   July 2001
Estimated Study Completion Date:   June 2003

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.

  Eligibility
Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria
  • Chronic congestive heart failure class II-III
  • No unstable angina
  • No myocardial infarction within 3 months
  • No peripheral neuropathy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00032422

Locations
United States, California
UCLA School of Medicine    
      Los Angeles, California, United States, 90095-1679

Sponsors and Collaborators

Investigators
Principal Investigator:     Holly R Middlekauff, MD     University of California, Los Angeles    
Investigator:     KaKit Hui, MD     UCLA East/West Medical Center    
  More Information

Publications:

Study ID Numbers:   R21 AT000671-01
First Received:   March 20, 2002
Last Updated:   August 17, 2006
ClinicalTrials.gov Identifier:   NCT00032422
Health Authority:   United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Acupuncture  
Heart Failure  
Autonomic nervous system  

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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