Acupuncture on Cardiac and Autonomic Function in Human Heart Failure

NCT01804816 | Completed Results DMC

• 1 other identifier: 12-580
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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. 1.To evaluate the effect of acupuncture treatment on human cardiac sympathetic/vagal activity
2. 2.To evaluate the effect of acupuncture treatment on cardiac function and functional capacity
3. 3.To evaluate the general health score of the quality-of-life with acupuncture treatment
4. 4.To explore the mechanism of acupuncture treatment on inflammation and nitrative stress in heart failure patients.

Conditions

Chronic Heart Failure

Keywords

Chronic Heart Failure; Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Change in Quality of Life (QOL)

  Baseline, Week 7, Week 13

Study Arms (2)

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.

Procedure: Acupuncture

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.

Other: No Intervention

Interventions

Acupuncture PROCEDURE

Standardized acupuncture administration for 10 sessions.

Acupuncture

No Intervention OTHER

No intervention during this period. This was a control period. Each subject acted as their own control.

No Acupuncture

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (4)

• 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.

  PMID: 12528093 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.

  PMID: 21216208 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.

  PMID: 21585058 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.

  PMID: 20554511 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Limitations and Caveats

These results should be interpreted with caution. With only 10 subjects, the study may be under-powered to detect a significant difference.

Results Point of Contact

• Title: Dr. W.H. Wilson Tang, MD
• Organization: Cleveland Clinic Foundation

(216) 444-2121

Study Officials

• W.H. Wilson Tang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Yanming Huang, MD PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cellular and Molecular Medicine and Cardiovascular Medicine

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 5, 2013
• Study Start: May 13, 2013
• Primary Completion: January 9, 2015
• Study Completion: December 1, 2021
• Last Updated: November 4, 2025
• Results First Posted: March 29, 2019

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)