Chronic Heart Failure
Conditions
Keywords
Chronic Heart Failure, Heart Failure
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.
Interventions
PROCEDUREAcupuncture
Standardized acupuncture administration for 10 sessions.
OTHERNo Intervention
No intervention during this period. This was a control period. Each subject acted as their own control.
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiac Function: LVEF | 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. |
| Change in 6-Minute Walk Distance | Baseline, Week 7, Week 13 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life (QOL) | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Cleveland Clinic Heart and Vascular Institute section of Heart Failure and Transplant Medicine.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| No Acupuncture/Acupuncture No Acupuncture: No treatment. Baseline period. Acupuncture: Standardized acupuncture administration for 10 sessions using acupuncture needles. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Acupuncture (second 5 weeks) | Physician Decision | 1 |
| No acupuncture (initial 5 weeks) | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | No Acupuncture/Acupuncture |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 55.9 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 2 / 14 |
Outcome results
Primary
Change in 6-Minute Walk Distance
Time frame: Baseline, Week 7, Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change in 6-Minute Walk Distance | 1376.2 Feet | Standard Deviation 250.19 |
| Pre-Acupuncture | Change in 6-Minute Walk Distance | 1488.0 Feet | Standard Deviation 264.82 |
| Post-Acupuncture | Change in 6-Minute Walk Distance | 1515.10 Feet | Standard Deviation 268.98 |
Comparison: Based on results from prior small clinical trials we estimate the need for 20 patients enrolled to reach 80% statistical power.p-value: 0.005t-test, 2 sided
p-value: 0.002t-test, 2 sided
p-value: 0.441t-test, 2 sided
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.
Time frame: Baseline, Week 7, Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change in Cardiac Function: LVEF | 36.14 LVEF Percentage | Standard Deviation 7.23 |
| Pre-Acupuncture | Change in Cardiac Function: LVEF | 36.11 LVEF Percentage | Standard Deviation 8.97 |
| Post-Acupuncture | Change in Cardiac Function: LVEF | 40.59 LVEF Percentage | Standard Deviation 9.28 |
p-value: 0.063t-test, 2 sided
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.
Time frame: Baseline, Week 7, Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change in Quality of Life (QOL) | 65.00 score on a scale | Standard Deviation 26.59 |
| Pre-Acupuncture | Change in Quality of Life (QOL) | 67.50 score on a scale | Standard Deviation 24.36 |
| Post-Acupuncture | Change in Quality of Life (QOL) | 69.17 score on a scale | Standard Deviation 25.78 |
p-value: 0.729t-test, 2 sided