Acupuncture, Heart Failure
Conditions
Keywords
Low-level Laser, Acupuncture therapy, Heart Failure
Brief summary
The advantages of laser acupuncture are a non-invasive, painless, low risk of infection and high safety. Laser acupuncture as a treatment tool has the following advantages1.Painless, 2. Non-invasive treatment, the subject is highly accepted, the risk of infection and needle stick is low, 3. Very few side effects such as fainting, bleeding, 4. The therapeutic dose is easy to operate, and the instrument output frequency, power and time can be controlled. Through the clinical physiological function test plus the verification and analysis of the quantitative test values, it will be more able to define the new role of laser acupuncture treatment in patients with heart failure from the perspective of Chinese medicine.
Detailed description
From the perspective of ancient books, the discussion of heart failure in the etiology and pathogenesis of traditional Chinese medicine was first seen in the Shu Wen. It is clearly pointed out that heart qi is the basic pathogenesis of heart failure. The qi and blood of Chinese medicine are closely related. The blood line is driven by the gas, the blood is bloody, and the qi deficiency is unable to push the blood to blood. If the qi deficiency, it would lead to blood stasis; There were studies have indicated that traditional acupuncture treatment can increase exercise tolerance and adjust autonomic nerve activity in patients with chronic heart failure, and can reduce their readmission rate and mortality rate in patients with acute heart failure. Studies using laser acupuncture to treat patients with heart failure have also found that they can increase the subject's six-minute walking distance.
Interventions
PROCEDUREAcupuncture
acupuncture at specific acupuncture points
DEVICELow-level laser therapy
low level laser emission on specific acupuncture points
Sponsors
National Yang Ming Chiao Tung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 20 years of age, with written informed consent. * NYHA:stage II-III. * All patients had LVEF \<40% caused by dilated or ischemic cardiomyopathy. * Acute HF patient presenting with dyspnea related to cardiogenic pulmonary edema. * All patients had sinus rhythm, were stable and compensated with individually optimized standard heart failure medication as well as oral anticoagulants for at least 3 months before (including prophylactic defibrillator placement). * Systolic blood pressure \> 95 mmHg at admission. * B-type natriuretic peptide (BNP) \> 150 pg/mL or NT-pro BNP \> 600 pg/mL.
Exclusion criteria
* Age under 20. * Major cardiovascular events and treatments occurred four weeks before hospitalization. * Major cardiovascular surgery or treatment will be performed in the next 6 months. * Pregnant or expected to pregnancy within a year. * Require a heart transplant in 6 months. * Uncontrolled atrial or ventricular dysrhythmias. * Uncompensated congestive heart failure. * Heart failure due to congenital heart disease or obstructive myocardial disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| N- terminal pro-brain natriuretic peptide, NT-proBNP | At the 12th week and 24th week | The change of NT-pro BNP from the date of admission to the end of trial |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| High sensitivity C-Reactive Protein, hs-CRP Hs-CRP | At the 12th week and 24th week | The change of NT-pro BNP from the date of admission to the end of trial |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaires_The Minnesota LIVING WITH HEART FAILURE® Questionnaire | At the 4th, 12t, 20th and 24th week | (MLHFQ);Scoring from 0 to 5 and higher scores mean better outcome. |
| Questionnaires_Patient Health Questionnaire-9 | At the 4th, 12t, 20th and 24th week | (PHQ-9);Scoring from 0 to 3 and higher scores mean worse outcome. |
| Questionnaires_Constitution in Chinese Medicine Questionnaire | At the 4th, 12th, 20th and 24th week | (CCMQ);Scoring from 1 to 5 and higher scores correspond to specific body constitution. |
| 6 minutes walking test | At the 4th, 12t, 20th and 24th week | (6 minutes walking distance, meters) |
| Left ventricular ejection fraction | At the 24th week | (Ejection fraction, %) |
| Heart rate variability_SDNN | At the 12th and 24th week | (Standard deviation of all normal to normal intervals, ms) |
| Questionnaires_Instrumental activities of daily living | At the 4th, 12t, 20th and 24th week | (IADL);Scoring from 0 to 4 and higher scores mean better outcome. |
| Heart rate variability_ASDNN | At the 12th and 24th week | (Average standard deviation of all 5-min R-R intervals, ms) |
| Heart rate variability_rMSSD | At the 12th and 24th week | (The square root of the mean of the sum of the squares of differences between adjacent NN intervals, ms) |
| Heart rate variability_LF | At the 12th and 24th week | (Low frequency power, normalized unit/ n.u. and ms2) |
| Heart rate variability_HF | At the 12th and 24th week | (High frequency power, normalized unit/ n.u. and ms2) |
| Heart rate variability_LF/HF | At the 12th and 24th week | (LF/HF Ratio) |
| Heart rate variability_SDANN index | At the 12th and 24th week | (Standard deviation of average normal to normal intervals index, ms) |
| Questionnaires_EuroQol- 5 Dimension | At the 4th, 12t, 20th and 24th week | (EQ-5D);Scoring from 1 to 3 and higher scores mean better outcome. |
Countries
Taiwan
Outcome results
None listed