Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
No Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring Chronic Heart Failure, Heart Failure
Eligibility 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)
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Acupuncture
No Acupuncture
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Change in 6-Minute Walk Distance
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01804816
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
To evaluate the effect of acupuncture treatment on human cardiac sympathetic/vagal activity
To evaluate the effect of acupuncture treatment on cardiac function and functional capacity
To evaluate the general health score of the quality-of-life with acupuncture treatment
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
Chronic Heart Failure, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
No Acupuncture
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Standardized acupuncture administration for 10 sessions.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
No intervention during this period. This was a control period. Each subject acted as their own control.
Primary Outcome Measure Information:
Title
Change in Cardiac Function: LVEF
Description
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.
Time Frame
Baseline, Week 7, Week 13
Title
Change in 6-Minute Walk Distance
Time Frame
Baseline, Week 7, Week 13
Secondary Outcome Measure Information:
Title
Change in Quality of Life (QOL)
Description
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.
Time Frame
Baseline, Week 7, Week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W.H. Wilson Tang, MD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanming Huang, MD PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make individual patient data available.
Citations:
PubMed Identifier
12528093
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.
Results Reference
background
PubMed Identifier
21216208
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.
Results Reference
background
PubMed Identifier
21585058
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.
Results Reference
background
PubMed Identifier
20554511
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.
Results Reference
background
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Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
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