Clinical trial NCT04383080: The Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.
Official title: The Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Acupuncture
Keywords: Low-level Laser
Acupuncture therapy
Heart Failure
Lead sponsor: National Yang Ming Chiao Tung University Hospital
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: N- terminal pro-brain natriuretic peptide, NT-proBNP
timeFrame: At the 12th week and 24th week
Secondary outcomes:
measure: High sensitivity C-Reactive Protein, hs-CRP Hs-CRP
timeFrame: At the 12th week and 24th week
Other outcomes:
measure: Questionnaires_Instrumental activities of daily living
timeFrame: At the 4th, 12t, 20th and 24th week
measure: Questionnaires_EuroQol- 5 Dimension
timeFrame: At the 4th, 12t, 20th and 24th week
measure: Questionnaires_The Minnesota LIVING WITH HEART FAILURE® Questionnaire
timeFrame: At the 4th, 12t, 20th and 24th week
measure: Questionnaires_Patient Health Questionnaire-9
timeFrame: At the 4th, 12t, 20th and 24th week
measure: Questionnaires_Constitution in Chinese Medicine Questionnaire
timeFrame: At the 4th, 12th, 20th and 24th week
measure: 6 minutes walking test
timeFrame: At the 4th, 12t, 20th and 24th week
measure: Left ventricular ejection fraction
timeFrame: At the 24th week
measure: Heart rate variability_SDNN
timeFrame: At the 12th and 24th week
measure: Heart rate variability_SDANN index
timeFrame: At the 12th and 24th week
measure: Heart rate variability_ASDNN
timeFrame: At the 12th and 24th week
measure: Heart rate variability_rMSSD
timeFrame: At the 12th and 24th week
measure: Heart rate variability_LF
timeFrame: At the 12th and 24th week
measure: Heart rate variability_HF
timeFrame: At the 12th and 24th week
measure: Heart rate variability_LF/HF
timeFrame: At the 12th and 24th week
Locations:
city: Ilan
country: Taiwan
facility: National Yang Ming University Hospital
Study officials:
affiliation: National Yang Ming Chiao Tung University Hospital
name: Shih Meng Chu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: