The Effect and Safety of Low-level Laser Therapy in Acute... | NCT04383080

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

NCT04383080

Sponsor

National Yang Ming Chiao Tung University Hospital

Status

Completed

Last Update Posted

Mar 24, 2023Actual

Enrollment

17Actual

Phase

Not Applicable

Conditions

Heart Failure
Acupuncture

Interventions

Acupuncture
Low-level laser therapy

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 17, 2022Actual

First Submitted Date

Apr 30, 2020

First Submission Date that Met QC Criteria

May 7, 2020

First Posted Date

May 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2023

Last Update Posted Date

Mar 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low-level laser therapy	Experimental	Low-level laser irradiation on specific acupuncture points	Device: Low-level laser therapy
Acupuncture therapy	Active Comparator	Dry needle inserting specific acupuncture points	Procedure: Acupuncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acupuncture	Procedure	acupuncture at specific acupuncture points	Acupuncture therapy

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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.

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shih Meng Chu, Bachelor	National Yang Ming Chiao Tung University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Yang Ming University Hospital		Yilan		26042	Taiwan

ID	Term
D006333	Heart Failure

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D015670	Acupuncture Therapy
D028022	Low-Level Light Therapy

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D053685	Laser Therapy
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided