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Completed

NCT Number: NCT04383080

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

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.

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Key information

Conditions

Heart Failure Acupuncture Cardiovascular Diseases Heart Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming University Hospital

Yilan, 26042, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Procedure

acupuncture at specific acupuncture points

Low-Level Laser Therapy

Device

low level laser emission on specific acupuncture points

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 6 minutes walking test

    Time frame: At the 4th, 12t, 20th and 24th week

    (6 minutes walking distance, meters)

  7. Left ventricular ejection fraction

    Time frame: At the 24th week

    (Ejection fraction, %)

  8. Heart rate variability_SDNN

    Time frame: At the 12th and 24th week

    (Standard deviation of all normal to normal intervals, ms)

  9. Heart rate variability_SDANN index

    Time frame: At the 12th and 24th week

    (Standard deviation of average normal to normal intervals index, ms)

  10. Heart rate variability_ASDNN

    Time frame: At the 12th and 24th week

    (Average standard deviation of all 5-min R-R intervals, ms)

  11. 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)

  12. Heart rate variability_LF

    Time frame: At the 12th and 24th week

    (Low frequency power, normalized unit/ n.u. and ms2)

  13. Heart rate variability_HF

    Time frame: At the 12th and 24th week

    (High frequency power, normalized unit/ n.u. and ms2)

  14. Heart rate variability_LF/HF

    Time frame: At the 12th and 24th week

    (LF/HF Ratio)

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 11, 2020
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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