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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Acupuncture
• Intervention / Treatment: Device: Low-level laser therapy; Procedure: Acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shih Meng Chu, Bachelor; Phone Number: 886-9-88-283-255; Email: shihmengchu@gmail.com

Study Locations

• Taiwan
  • Ilan, Taiwan, 26042
    • National Yang Ming University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaires_Instrumental activities of daily living	(IADL);Scoring from 0 to 4 and higher scores mean better outcome.	At the 4th, 12t, 20th and 24th week
Questionnaires_EuroQol- 5 Dimension	(EQ-5D);Scoring from 1 to 3 and higher scores mean better outcome.	At the 4th, 12t, 20th and 24th week
Questionnaires_The Minnesota LIVING WITH HEART FAILURE® Questionnaire	(MLHFQ);Scoring from 0 to 5 and higher scores mean better outcome.	At the 4th, 12t, 20th and 24th week
Questionnaires_Patient Health Questionnaire-9	(PHQ-9);Scoring from 0 to 3 and higher scores mean worse outcome.	At the 4th, 12t, 20th and 24th week
Questionnaires_Constitution in Chinese Medicine Questionnaire	(CCMQ);Scoring from 1 to 5 and higher scores correspond to specific body constitution.	At the 4th, 12th, 20th and 24th week
6 minutes walking test	(6 minutes walking distance, meters)	At the 4th, 12t, 20th and 24th week
Left ventricular ejection fraction	(Ejection fraction, %)	At the 24th week
Heart rate variability_SDNN	(Standard deviation of all normal to normal intervals, ms)	At the 12th and 24th week
Heart rate variability_SDANN index	(Standard deviation of average normal to normal intervals index, ms)	At the 12th and 24th week
Heart rate variability_ASDNN	(Average standard deviation of all 5-min R-R intervals, ms)	At the 12th and 24th week
Heart rate variability_rMSSD	(The square root of the mean of the sum of the squares of differences between adjacent NN intervals, ms)	At the 12th and 24th week
Heart rate variability_LF	(Low frequency power, normalized unit/ n.u. and ms2)	At the 12th and 24th week
Heart rate variability_HF	(High frequency power, normalized unit/ n.u. and ms2)	At the 12th and 24th week
Heart rate variability_LF/HF	(LF/HF Ratio)	At the 12th and 24th week

Collaborators and Investigators

• Sponsor: National Yang Ming Chiao Tung University Hospital
• Investigators: Principal Investigator: Shih Meng Chu, Bachelor, National Yang Ming Chiao Tung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 17, 2022

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Heart Failure; Acupuncture therapy; Low-level Laser
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: NYMUH IRB No.2019b007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No