- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00032422
Acupuncture in Cardiovascular Disease
August 17, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
The purpose of this study is to determine if acupuncture decreases adrenaline levels in heart failure, thereby potentially improving survival and quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095-1679
- UCLA School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- Chronic congestive heart failure class II-III
- No unstable angina
- No myocardial infarction within 3 months
- No peripheral neuropathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Holly R Middlekauff, MD, University of California, Los Angeles
- KaKit Hui, MD, UCLA East/West Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2001
Study Completion
June 1, 2003
Study Registration Dates
First Submitted
March 20, 2002
First Submitted That Met QC Criteria
March 21, 2002
First Posted (Estimate)
March 22, 2002
Study Record Updates
Last Update Posted (Estimate)
August 18, 2006
Last Update Submitted That Met QC Criteria
August 17, 2006
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21AT000671-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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