N/A
N=14
Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
Chronic Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT01804816 ↗Enrolled (actual)
14
Serious AEs
14.3%
Results posted
Mar 2019
Primary outcome: Primary: Change in Cardiac Function: LVEF — 36.14; 36.11; 40.59 LVEF Percentage — p=0.063
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acupuncture (Procedure); No Intervention (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Cardiac Function: LVEF |
36.14; 36.11; 40.59 | 0.063 |
| PRIMARY Change in 6-Minute Walk Distance |
1376.2; 1488.0; 1515.10 | 0.005 sig |
| SECONDARY Change in Quality of Life (QOL) |
65.00; 67.50; 69.17 | 0.729 |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01804816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.