The Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.

Conditions
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Heart Failure, Acupuncture

Intervention / Treatment
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* Procedure: Acupuncture
* Device: Low-level laser therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-level laser therapy<br>Low-level laser irradiation on specific acupuncture points | Device: Low-level laser therapy<br>* low level laser emission on specific acupuncture points<br>|
| Active Comparator: Acupuncture therapy<br>Dry needle inserting specific acupuncture points | Procedure: Acupuncture<br>* acupuncture at specific acupuncture points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N- terminal pro-brain natriuretic peptide, NT-proBNP | The change of NT-pro BNP from the date of admission to the end of trial | At the 12th week and 24th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High sensitivity C-Reactive Protein, hs-CRP Hs-CRP | The change of NT-pro BNP from the date of admission to the end of trial | At the 12th week and 24th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-level Laser, Acupuncture therapy, Heart Failure