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

NCT ID: NCT04383080

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-12-17

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.

Conditions

Heart Failure; Acupuncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Low-level laser therapy

Low-level laser irradiation on specific acupuncture points

Group Type: EXPERIMENTAL

Low-level laser therapy

Intervention Type: DEVICE

low level laser emission on specific acupuncture points

Acupuncture therapy

Dry needle inserting specific acupuncture points

Group Type: ACTIVE_COMPARATOR

Acupuncture

Intervention Type: PROCEDURE

acupuncture at specific acupuncture points

Interventions

Acupuncture

acupuncture at specific acupuncture points

Intervention Type: PROCEDURE

Low-level laser therapy

low level laser emission on specific acupuncture points

Intervention Type: DEVICE

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Yang Ming Chiao Tung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shih Meng Chu, Bachelor

Role: PRINCIPAL_INVESTIGATOR

National Yang Ming Chiao Tung University Hospital

Locations

National Yang Ming University Hospital

Yilan, , Taiwan

Countries

Taiwan

Other Identifiers

NYMUH IRB No.2019b007

Identifier Type: -

Identifier Source: org_study_id