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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 20, 2002 | ||||||||
| Last Updated Date | August 17, 2006 | ||||||||
| Start Date ICMJE | July 2001 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00032422 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Acupuncture in Cardiovascular Disease | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Congestive Heart Failure | ||||||||
| Intervention ICMJE | Procedure: Acupuncture | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 200 | ||||||||
| Completion Date | June 2003 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE |
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| Gender | Both | ||||||||
| Ages | 21 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00032422 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | R21 AT000671-01 | ||||||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||||||
| Verification Date | July 2006 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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