Chronic Heart FailureNCT01804816

Acupuncture on Cardiac and Autonomic Function in Human Heart Failure

A study testing Acupuncture in people with Chronic Heart Failure, run by The Cleveland Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Chronic Heart Failure
What is being tested?: Acupuncture
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 13 May 2013to Dec 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic
Cleveland, Ohio, 44195

Other trials in United States

About this study

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.

Read the 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.

Conditions: Chronic Heart Failure
Being tested: Acupuncture, No Intervention
Keywords: Chronic Heart Failure, Heart Failure
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcupunctureProcedure or surgery
Standardized acupuncture administration for 10 sessions.
No InterventionOther
No intervention during this period. This was a control period. Each subject acted as their own control.

Study groups in NCT01804816
Study group	Role	What they receive
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. Receives: 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. Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 7, Week 13
Change in 6-Minute Walk Distance
Measured: Baseline, Week 7, Week 13

Secondary outcomes (1)

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.
Measured: Baseline, Week 7, Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 2013Dec 2021

First posted5 Mar 2013 (estimated)
Study start13 May 2013
Primary completion9 Jan 2015
Study completionDec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01804816
Sponsor's protocol ID: 12-580
Status last verified: Oct 2026
First submitted: 4 Mar 2013
Last updated: 20 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: There is no plan to make individual patient data available.

Publications

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.
PubMed 12528093
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.
PubMed 21216208
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.
PubMed 21585058
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.
PubMed 20554511

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupuncture on Cardiac and Autonomic Function in Human Heart Failure
ClinicalTrials.gov ID: NCT01804816
Acronym / sponsor ID: 12-580
Conditions: Chronic Heart Failure
Keywords: Chronic Heart Failure, Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: 13 May 2013 (actual)
Primary completion: 9 Jan 2015 (actual)
Study completion: Dec 2021 (actual)
First posted: 5 Mar 2013 (estimated)
Results: Posted 29 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Acupuncture	Experimental	Procedure: Acupuncture10 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	Placebo comparator	Other: No InterventionNo 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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcupunctureStandardized acupuncture administration for 10 sessions.	Procedure or surgery	Acupuncture
No InterventionNo intervention during this period. This was a control period. Each subject acted as their own control.	Other	No Acupuncture

Primary outcome

Change in Cardiac Function: LVEF
Time frame: 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
Time frame: Baseline, Week 7, Week 13

1 secondary outcome

Change in Quality of Life (QOL)
Time frame: Baseline, Week 7, Week 13

Results and safety

Results posted to the registry on 29 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
No Acupuncture / Acupuncture	14	11

Primary outcome: Change in Cardiac Function: LVEF

Time frame: Baseline, Week 7, Week 13. Mean (Standard Deviation). Unit: LVEF Percentage

Measure	Baseline n = 10	Pre-Acupuncture n = 10	Post-Acupuncture n = 10
Value	36.14 (7.23)	36.11 (8.97)	40.59 (9.28)

Baseline vs Post-Acupuncture: p = 0.063, t-test, 2 sided

Primary outcome: Change in 6-Minute Walk Distance

Time frame: Baseline, Week 7, Week 13. Mean (Standard Deviation). Unit: Feet

Measure	Baseline n = 10	Pre-Acupuncture n = 10	Post-Acupuncture n = 10
Value	1376.2 (250.19)	1488.0 (264.82)	1515.10 (268.98)

Baseline vs Pre-Acupuncture: p = 0.005, t-test, 2 sided
Baseline vs Post-Acupuncture: p = 0.002, t-test, 2 sided
Pre-Acupuncture vs Post-Acupuncture: p = 0.441, t-test, 2 sided

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Acupuncture/Acupuncture	2 of 14 (14.3%)	0 of 14 (0%)	0 of 14

Limitations and caveats (from the sponsor): These results should be interpreted with caution. With only 10 subjects, the study may be under-powered to detect a significant difference.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12528093Middlekauff 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.
Background: PubMed 21216208Kurono 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.
Background: PubMed 21585058Deng 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.
Background: PubMed 20554511Kristen 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.
Individual participant dataSharing planned: No. There is no plan to make individual patient data available.

Related trials for Chronic Heart Failure

Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingPhase 3
Qishen Yiqi Dripping Pills in Treatment of Chronic Heart FailUre
Heart Failure
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
Not yet recruiting
Exercise, Mediterranean Diet and Inflammation in Heart Failure
Heart Failure, Heart Failure Preserved Ejection Fraction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

W.H. Wilson Tang, MD principal investigator

The Cleveland Clinic

Yanming Huang, MD PhD principal investigator

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Chronic Heart Failure, run by The Cleveland Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cardiac Function: LVEF (time frame: Baseline, Week 7, Week 13). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01804816, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.