CompletedNot Applicable

Acupuncture on Cardiac and Autonomic Function in Human Heart Failure

United States14 participantsStarted 2013-05-13

Plain-language 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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Cardiac Function: LVEF

Timeframe: Baseline, Week 7, Week 13

Change in 6-Minute Walk Distance

Timeframe: Baseline, Week 7, Week 13

Trial details

NCT IDNCT01804816

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-01-09

Results submitted2018-06-05

View on ClinicalTrials.gov More Chronic Heart Failure trials