Acupuncture in Cardiovascular Disease

Status Completed

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00032422
Study type	Interventional
Source	National Center for Complementary and Integrative Health (NCCIH)
Contact
Status	Completed
Phase	Phase 2
Start date	July 2001
Completion date	June 2003

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04115735` - His Bundle Recording From Subclavian Vein
Recruiting	`NCT05562037` - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA	N/A
Completed	`NCT05563701` - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting	`NCT05865184` - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed	`NCT04037436` - Functional Exercise and Nutrition Education Program for Older Adults	N/A
Recruiting	`NCT04703842` - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction	Phase 1/Phase 2
Terminated	`NCT05594940` - Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Recruiting	`NCT04982081` - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection	Phase 1
Completed	`NCT04394754` - Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure	N/A
Active, not recruiting	`NCT01385176` - Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)	N/A
Not yet recruiting	`NCT05516290` - Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
Completed	`NCT02885636` - Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial	Phase 3
Terminated	`NCT02788656` - Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan)	Phase 4
Terminated	`NCT02205411` - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation	N/A
Completed	`NCT02252757` - Assess Measurements of Wireless Cardiac Output Device	N/A
Completed	`NCT01362855` - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Withdrawn	`NCT00346177` - Stem Cell Study for Patients With Heart Failure	Phase 2
Active, not recruiting	`NCT01058837` - SCD-HeFT 10 Year Follow-up	N/A
Completed	`NCT00957541` - Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.