Back to resultsThe Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.
Primary Purpose
Heart Failure, Acupuncture
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Low-level laser therapy
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Low-level Laser, Acupuncture therapy, Heart Failure
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
Sites / Locations
- National Yang Ming University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Low-level laser therapy
Acupuncture therapy
Arm Description
Low-level laser irradiation on specific acupuncture points
Dry needle inserting specific acupuncture points
Outcomes
Primary Outcome Measures
N- terminal pro-brain natriuretic peptide, NT-proBNP
The change of NT-pro BNP from the date of admission to the end of trial
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04383080
First Posted
April 30, 2020
Last Updated
March 22, 2023
Sponsor
National Yang Ming Chiao Tung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04383080
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming Chiao Tung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Acupuncture
Keywords
Low-level Laser, Acupuncture therapy, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low-level laser therapy
Arm Type
Experimental
Arm Description
Low-level laser irradiation on specific acupuncture points
Arm Title
Acupuncture therapy
Arm Type
Active Comparator
Arm Description
Dry needle inserting specific acupuncture points
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
acupuncture at specific acupuncture points
Intervention Type
Device
Intervention Name(s)
Low-level laser therapy
Intervention Description
low level laser emission on specific acupuncture points
Primary Outcome Measure Information:
Title
N- terminal pro-brain natriuretic peptide, NT-proBNP
Description
The change of NT-pro BNP from the date of admission to the end of trial
Time Frame
At the 12th week and 24th week
Secondary Outcome Measure Information:
Title
High sensitivity C-Reactive Protein, hs-CRP Hs-CRP
Description
The change of NT-pro BNP from the date of admission to the end of trial
Time Frame
At the 12th week and 24th week
Other Pre-specified Outcome Measures:
Title
Questionnaires_Instrumental activities of daily living
Description
(IADL);Scoring from 0 to 4 and higher scores mean better outcome.
Time Frame
At the 4th, 12t, 20th and 24th week
Title
Questionnaires_EuroQol- 5 Dimension
Description
(EQ-5D);Scoring from 1 to 3 and higher scores mean better outcome.
Time Frame
At the 4th, 12t, 20th and 24th week
Title
Questionnaires_The Minnesota LIVING WITH HEART FAILURE® Questionnaire
Description
(MLHFQ);Scoring from 0 to 5 and higher scores mean better outcome.
Time Frame
At the 4th, 12t, 20th and 24th week
Title
Questionnaires_Patient Health Questionnaire-9
Description
(PHQ-9);Scoring from 0 to 3 and higher scores mean worse outcome.
Time Frame
At the 4th, 12t, 20th and 24th week
Title
Questionnaires_Constitution in Chinese Medicine Questionnaire
Description
(CCMQ);Scoring from 1 to 5 and higher scores correspond to specific body constitution.
Time Frame
At the 4th, 12th, 20th and 24th week
Title
6 minutes walking test
Description
(6 minutes walking distance, meters)
Time Frame
At the 4th, 12t, 20th and 24th week
Title
Left ventricular ejection fraction
Description
(Ejection fraction, %)
Time Frame
At the 24th week
Title
Heart rate variability_SDNN
Description
(Standard deviation of all normal to normal intervals, ms)
Time Frame
At the 12th and 24th week
Title
Heart rate variability_SDANN index
Description
(Standard deviation of average normal to normal intervals index, ms)
Time Frame
At the 12th and 24th week
Title
Heart rate variability_ASDNN
Description
(Average standard deviation of all 5-min R-R intervals, ms)
Time Frame
At the 12th and 24th week
Title
Heart rate variability_rMSSD
Description
(The square root of the mean of the sum of the squares of differences between adjacent NN intervals, ms)
Time Frame
At the 12th and 24th week
Title
Heart rate variability_LF
Description
(Low frequency power, normalized unit/ n.u. and ms2)
Time Frame
At the 12th and 24th week
Title
Heart rate variability_HF
Description
(High frequency power, normalized unit/ n.u. and ms2)
Time Frame
At the 12th and 24th week
Title
Heart rate variability_LF/HF
Description
(LF/HF Ratio)
Time Frame
At the 12th and 24th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shih Meng Chu, Bachelor
Organizational Affiliation
National Yang Ming Chiao Tung University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Yang Ming University Hospital
City
Ilan
ZIP/Postal Code
26042
Country
Taiwan
12. IPD Sharing Statement
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The Effect and Safety of Low-level Laser Therapy in Acute Decompensated Heart Failure Patients.
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