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Acupuncture on Cardiac and Autonomic Function in Human Heart Failure

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ClinicalTrials.gov Identifier: NCT01804816
Recruitment Status : Active, not recruiting
First Posted : March 5, 2013
Results First Posted : March 29, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Wilson Tang, The Cleveland Clinic

Brief Summary:

Acupuncture treatment may improve the cardiac function and the quality of life in heart failure patients. These effects may be related to the inhibition of sympathetic activity and/or increased vagal function. The suppression of inflammatory reaction with acupuncture treatment may also be associated with these outcomes. Specific aims include:

  1. To evaluate the effect of acupuncture treatment on human cardiac sympathetic/vagal activity
  2. To evaluate the effect of acupuncture treatment on cardiac function and functional capacity
  3. To evaluate the general health score of the quality-of-life with acupuncture treatment
  4. To explore the mechanism of acupuncture treatment on inflammation and nitrative stress in heart failure patients.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Procedure: Acupuncture Other: No Intervention Not Applicable

Detailed Description:

The primary aim of this study is to evaluate the effect of acupuncture treatment on cardiac sympathetic/vagal activity in chronic heart failure patients. The investigators would like to investigate the effect of acupuncture treatment on cardiac function and the general health score of the quality-of-life. The investigators would like to further explore the mechanism of acupuncture treatment on autonomic imbalance and chronic inflammatory reaction in heart failure patients by comparing the treatment and sham groups, the baseline before the treatment and the changes after treatment.

Chronic heart failure affects millions people and is a leading cause of death in US. Despite of advance in diagnoses and treatments, the long-term prognosis and quality of life of chronic heart failure patients remain poor. The mortality of chronic heart failure is estimated 50% within 4 years, and is more than 50% in patients with severe chronic heart failure.

Chronic heart failure results from the left ventricular (LV) systolic and/or diastolic dysfunction. Autonomic imbalance with sustained sympathetic overdrive and vagal withdrawal plays an important role in the development of chronic heart failure. This autonomic dysregulation is related to increased heart rate, excess inflammatory response, progressive LV dysfunction, increased mortality and morbidity in chronic heart failure patients. Sympathetic active inhibition with beta-adrenergic receptor blockers has shown significant reduction in mortality and morbidity in chronic heart failure patients. Also modulation of parasympathetic activation with electrical vagus nerve stimulation (VNS) has demonstrated as a potential therapy for chronic heart failure.

Acupuncture has been widely used in China for thousands of years to treat a variety of diseases and their symptoms. Except pain disorders, increasing evidences have shown that acupuncture may be useful for cardiovascular diseases, such as coronary artery disease, hypertension and chronic heart failure. It has been demonstrated that certain acupuncture points have shown to inhibit cardiac sympathetic activation or increase cardiac vagal component in both experimental animals and clinical studies. Recently a small clinical trial by Dr. Kristen, et al has found that acupuncture could improve exercise tolerance in chronic heart failure patients.

The investigators hypothesize that acupuncture treatment may improve the cardiac function and the quality of life in heart failure patients. These effects may be related to the inhibition of sympathetic activity and/or increased vagal function. The suppression of inflammatory reaction with acupuncture treatment may also be associated with these outcomes. In addition to optimized standard heart failure medications, acupuncture may be a safe therapeutic strategy in chronic heart failure treatment. Studies of acupuncture on cardiac autonomic activity in heart failure may show more evidence of acupuncture treatment in chronic heart failure patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
Study Start Date : February 2013
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
10 standardized verum acupuncture (VA) sessions twice a week, over 5 weeks. The 5 weeks of acupuncture were scheduled after the period of no acupuncture for each subject.
Procedure: Acupuncture
Standardized acupuncture administration for 10 sessions.

Placebo Comparator: No Acupuncture
No acupuncture treatment or other study intervention over 5 weeks. All subjects had a 5 week period of "no acupuncture" prior to the 5 weeks of acupuncture sessions.
Other: No Intervention
No intervention during this period. This was a control period. Each subject acted as their own control.




Primary Outcome Measures :
  1. Change in Cardiac Function: LVEF [ Time Frame: Baseline, Week 7, Week 13 ]
    Left ventricular ejection fraction (LVEF) percentage was measured at baseline, after 5 weeks of no treatment and just prior to acupuncture treatment, and after 5 weeks of acupuncture treatments.

  2. Change in 6-Minute Walk Distance [ Time Frame: Baseline, Week 7, Week 13 ]

Secondary Outcome Measures :
  1. Change in Quality of Life (QOL) [ Time Frame: Baseline, Week 7, Week 13 ]
    Patients quality of life (QOL) was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, after 5 weeks of no treatment and just prior to acupuncture treatment, and after 5 weeks of acupuncture treatments. Scores reported here are the Quality of Life Scores, which range from 0 to 100. Higher numbers indicate a better quality of life.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 21 years
  • Congestive Heart Failure (CHF), New York Heart Association (NYHA) class II-III, LVEF ≤40%
  • All patients will have sinus rhythm and compensate with individually optimized standard heart failure medications. Routine medications will be continued during the study period
  • Able and willing to give informed consent or comply with study procedures.

Exclusion Criteria:

  • Acupuncture treatment within 3 months before the beginning of the study
  • Presents with cutaneous eczema at potential acupoints
  • Have a history of major bleeding or increased propensity of excessive bleeding due to platelet dysfunction
  • Currently taking anti-coagulants (e.g. warfarin)

Information from the National Library of Medicine

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): NCT01804816


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: W.H. Wilson Tang, MD The Cleveland Clinic
Principal Investigator: Yanming Huang, MD PhD The Cleveland Clinic

Publications:
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Responsible Party: Wilson Tang, Staff Cellular and Molecular Medicine and Cardiovascular Medicine, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01804816     History of Changes
Other Study ID Numbers: 12-580
First Posted: March 5, 2013    Key Record Dates
Results First Posted: March 29, 2019
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual patient data available.

Keywords provided by Wilson Tang, The Cleveland Clinic:
Chronic Heart Failure
Heart Failure

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases