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

March 22, 2023 updated by: National Yang Ming Chiao Tung University Hospital
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
N- terminal pro-brain natriuretic peptide, NT-proBNP
Time Frame: At the 12th week and 24th week
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
High sensitivity C-Reactive Protein, hs-CRP Hs-CRP
Time Frame: At the 12th week and 24th week
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Questionnaires_Instrumental activities of daily living
Time Frame: At the 4th, 12t, 20th and 24th week
(IADL);Scoring from 0 to 4 and higher scores mean better outcome.
At the 4th, 12t, 20th and 24th week
Questionnaires_EuroQol- 5 Dimension
Time Frame: At the 4th, 12t, 20th and 24th week
(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
Time Frame: At the 4th, 12t, 20th and 24th week
(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
Time Frame: At the 4th, 12t, 20th and 24th week
(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
Time Frame: At the 4th, 12th, 20th and 24th week
(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
Time Frame: At the 4th, 12t, 20th and 24th week
(6 minutes walking distance, meters)
At the 4th, 12t, 20th and 24th week
Left ventricular ejection fraction
Time Frame: At the 24th week
(Ejection fraction, %)
At the 24th week
Heart rate variability_SDNN
Time Frame: At the 12th and 24th week
(Standard deviation of all normal to normal intervals, ms)
At the 12th and 24th week
Heart rate variability_SDANN index
Time Frame: At the 12th and 24th week
(Standard deviation of average normal to normal intervals index, ms)
At the 12th and 24th week
Heart rate variability_ASDNN
Time Frame: At the 12th and 24th week
(Average standard deviation of all 5-min R-R intervals, ms)
At the 12th and 24th week
Heart rate variability_rMSSD
Time Frame: 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)
At the 12th and 24th week
Heart rate variability_LF
Time Frame: At the 12th and 24th week
(Low frequency power, normalized unit/ n.u. and ms2)
At the 12th and 24th week
Heart rate variability_HF
Time Frame: At the 12th and 24th week
(High frequency power, normalized unit/ n.u. and ms2)
At the 12th and 24th week
Heart rate variability_LF/HF
Time Frame: At the 12th and 24th week
(LF/HF Ratio)
At the 12th and 24th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming Chiao Tung University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shih Meng Chu, Bachelor, National Yang Ming Chiao Tung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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