Overview

This trial is active, not recruiting.

Condition chronic heart failure
Treatment acupuncture
Phase phase 2
Sponsor The Cleveland Clinic
Start date February 2013
End date December 2016
Trial size 20 participants
Trial identifier NCT01804816, 12-580

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Acupuncture needles
acupuncture
Standardized acupuncture administration for 10 sessions.
(Placebo Comparator)
"no acupuncture treatment"
acupuncture
Standardized acupuncture administration for 10 sessions.

Primary Outcomes

Measure
Change in Cardiac Function
time frame: From baseline to 13 weeks

Secondary Outcomes

Measure
Change in Heart Rate Variability
time frame: From baseline to 13 weeks

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Age ≥ 21 years - 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)

Additional Information

Official title Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
Principal investigator W.H. Wilson Tang, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.