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Acupuncture in Cardiovascular Disease

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ClinicalTrials.gov Identifier: NCT00032422
Recruitment Status : Completed
First Posted : March 22, 2002
Last Update Posted : August 18, 2006
Sponsor:
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Procedure: Acupuncture Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Acupuncture in Cardiovascular Disease
Study Start Date : July 2001
Study Completion Date : June 2003

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032422


Locations
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United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095-1679
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Holly R Middlekauff, MD University of California, Los Angeles
OverallOfficial: KaKit Hui, MD UCLA East/West Medical Center
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00032422    
Other Study ID Numbers: R21AT000671-01 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2002    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: July 2006
Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Acupuncture
Heart Failure
Autonomic nervous system
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases