Clinical trial NCT01804816: Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
Official title: Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure
Heart Failure
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 21 years
* Congestive Heart Failure (CHF), New York Heart Association (NYHA) class II-III, Left Ventricular Eject Fraction (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)

Primary outcomes:
measure: Change in Cardiac Function: LVEF
timeFrame: Baseline, Week 7, Week 13
measure: Change in 6-Minute Walk Distance
timeFrame: Baseline, Week 7, Week 13
Secondary outcomes:
measure: Change in Quality of Life (QOL)
timeFrame: Baseline, Week 7, Week 13
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: W.H. Wilson Tang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Yanming Huang, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Middlekauff HR, Hui K, Yu JL, Hamilton MA, Fonarow GC, Moriguchi J, Maclellan WR, Hage A. Acupuncture inhibits sympathetic activation during mental stress in advanced heart failure patients. J Card Fail. 2002 Dec;8(6):399-406. doi: 10.1054/jcaf.2002.129656.
citation: Kurono Y, Minagawa M, Ishigami T, Yamada A, Kakamu T, Hayano J. Acupuncture to Danzhong but not to Zhongting increases the cardiac vagal component of heart rate variability. Auton Neurosci. 2011 Apr 26;161(1-2):116-20. doi: 10.1016/j.autneu.2010.12.003. Epub 2011 Jan 7.
citation: Deng YJ, Liang WX, Cheng SY. [Influence of acupoint-catgut-implantation on blood pressure and cardiac function in chronic congestive heart failure rats]. Zhen Ci Yan Jiu. 2011 Feb;36(1):40-5. Chinese.
citation: Kristen AV, Schuhmacher B, Strych K, Lossnitzer D, Friederich HC, Hilbel T, Haass M, Katus HA, Schneider A, Streitberger KM, Backs J. Acupuncture improves exercise tolerance of patients with heart failure: a placebo-controlled pilot study. Heart. 2010 Sep;96(17):1396-400. doi: 10.1136/hrt.2009.187930. Epub 2010 Jun 15.