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Acupuncture on Cardiac and Autonomic Function in Human Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Wilson Tang, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01804816
First received: March 4, 2013
Last updated: December 19, 2013
Last verified: December 2013

March 4, 2013
December 19, 2013
February 2013
October 2014   (final data collection date for primary outcome measure)
Change in Cardiac Function [ Time Frame: From baseline to 13 weeks ] [ Designated as safety issue: No ]
Change in Cardiac Function [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01804816 on ClinicalTrials.gov Archive Site
Change in Heart Rate Variability [ Time Frame: From baseline to 13 weeks ] [ Designated as safety issue: No ]
  • Change in Heart Rate Variability [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change in Heart Rate Variability [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Change in Heart Rate Variability [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
Acupuncture on Cardiac and Autonomic Function in Human Heart Failure

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Heart Failure
Procedure: Acupuncture
Other Name: Standardized acupuncture administration for 10 sessions.
  • Experimental: Acupuncture
    Acupuncture needles
    Intervention: Procedure: Acupuncture
  • Placebo Comparator: No Acupuncture
    "no acupuncture treatment"

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
October 2015
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 21 years
  • 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)
Both
21 Years and older
No
Contact: Jennifer Kirsop, BS 216-636-6153 kirsopj@ccf.org
United States
 
NCT01804816
12-580
Yes
Wilson Tang, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: W.H. Wilson Tang, MD The Cleveland Clinic
Principal Investigator: Yanming Huang, MD PhD The Cleveland Clinic
The Cleveland Clinic
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP