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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Experimental | 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. |
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| No Acupuncture | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Standardized acupuncture administration for 10 sessions. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiac Function: LVEF | 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. | Baseline, Week 7, Week 13 |
| Change in 6-Minute Walk Distance | Baseline, Week 7, Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life (QOL) | 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. | Baseline, Week 7, Week 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| W.H. Wilson Tang, MD | The Cleveland Clinic | Principal Investigator |
| Yanming Huang, MD PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12528093 | Background | 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. | |
| 21216208 | Background | 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. |
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There is no plan to make individual patient data available.
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All subjects acted as their own controls for this study and were assigned to a 5 week period of no acupuncture or other study interventions (control) followed by a 5 week period of weekly standardized verum acupuncture (intervention).
Participants were recruited from the Cleveland Clinic Heart and Vascular Institute section of Heart Failure and Transplant Medicine.
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| ID | Title | Description |
|---|---|---|
| FG000 | No Acupuncture / Acupuncture | 5 weeks of no treatment followed by 5 weeks of standardized verum acupuncture. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No acupuncture (initial 5 weeks) |
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| Acupuncture (second 5 weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Acupuncture/Acupuncture | No Acupuncture: No treatment. Baseline period. Acupuncture: Standardized acupuncture administration for 10 sessions using acupuncture needles. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Cardiac Function: LVEF | 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. | Posted | Mean | Standard Deviation | LVEF Percentage | Baseline, Week 7, Week 13 |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Acupuncture/Acupuncture | No Acupuncture: No treatment. Baseline period. Acupuncture: Standardized acupuncture administration for 10 sessions using acupuncture needles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Cardiac disorders | Non-systematic Assessment | Subjects were hospitalized for worsening heart failure, which was not unanticipated since a diagnosis of heart failure and a decreased left ventricular ejection fraction were required for study inclusion. Hospitalizations were subject-reported. |
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These results should be interpreted with caution. With only 10 subjects, the study may be under-powered to detect a significant difference.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. W.H. Wilson Tang, MD | Cleveland Clinic Foundation | (216) 444-2121 |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| No Intervention |
| Other |
No intervention during this period. This was a control period. Each subject acted as their own control. |
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| 21585058 | Background | 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. |
| 20554511 | Background | 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. |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Measurements were taken after 10 sessions of standardized verum acupuncture administration using 0.18-0.25×30-60-mm stainless steel needles. Acupuncture sessions were scheduled twice a week for 5 weeks. This post-acupuncture visit occurred within 1 week of finishing the acupuncture sessions. |
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| Primary | Change in 6-Minute Walk Distance | Posted | Mean | Standard Deviation | Feet | Baseline, Week 7, Week 13 |
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| Secondary | Change in Quality of Life (QOL) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 7, Week 13 |
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| 0 |
| 14 |
| 2 |
| 14 |
| 0 |
| 14 |
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| 0.002 |
| Equivalence |
a=0.05 |
| t-test, 2 sided | 0.441 | Equivalence | a=0.05 |