NCT04383080

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2022

Completed
Last Updated

March 24, 2023

Status Verified

October 1, 2022

Enrollment Period

2.4 years

First QC Date

April 30, 2020

Last Update Submit

March 22, 2023

Conditions

Heart FailureAcupuncture

Keywords

Low-level LaserAcupuncture therapyHeart Failure

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • High sensitivity C-Reactive Protein, hs-CRP Hs-CRP

    At the 12th week and 24th week

Other Outcomes (14)

  • Questionnaires_Instrumental activities of daily living

    At the 4th, 12t, 20th and 24th week

  • Questionnaires_EuroQol- 5 Dimension

    At the 4th, 12t, 20th and 24th week

  • Questionnaires_The Minnesota LIVING WITH HEART FAILURE® Questionnaire

    At the 4th, 12t, 20th and 24th week

  • +11 more other outcomes

Study Arms (2)

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

AcupuncturePROCEDURE

acupuncture at specific acupuncture points

Acupuncture therapy
Low-level laser therapyDEVICE

low level laser emission on specific acupuncture points

Low-level laser therapy

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming University Hospital

Yilan, 26042, Taiwan

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Acupuncture TherapyLow-Level Light Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsLaser TherapyPhototherapy

Study Officials

  • Shih Meng Chu, Bachelor

    National Yang Ming Chiao Tung University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 11, 2020

Study Start

July 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 17, 2022

Last Updated

March 24, 2023

Record last verified: 2022-10

Locations

TW(1)