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NCT Number: NCT06501313

PhotobiomoduLation for pAtientS With Advanced hEart failuRe

The objective of the study is to examine the effectiveness of photobiomodulation therapy in patients with advanced-stage heart failure with reduced ejection fraction (HFrEF), who have been referred but ineligible for a heart transplantation. The primary endpoint is a 15% relative reduction in left ventricular end-systolic volume (LV ESV) as determined by echocardiography over a 12-month follow-up period. The secondary objective is to determine the change in NT-proBNP, a biomarker for heart failure, the change in heart failure symptoms based on the NYHA functional classification, the change in quality of life questionnaire (KCCQ), additional echocardiographic parameters, and the detection of changes in heart failure and fibrosis biomarkers. Additionally, the study aims to examine hospitalization due to heart failure and overall mortality.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Systolic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Advanced-stage HFrEF patients who were ineligible for heart transplantation Patients over 18 years of age The expected lifespan exceeds 1 year Consent form

Exclusion criteria

Non-compliant patient Pregnant women Drug or alcohol abuse The patient is participating in another clinical trial

Treatment and study plan

Photobiomodulation

Device

Soft laser therapy

Primary outcomes

  1. Echocardiographic response

    Time frame: 12 months

    At least 15% reduction of end-systolic volume

Secondary outcomes

  1. Other echocardiographic response

    Time frame: 12 months

    strain alanysis, LVEF, EDV, ESV

  2. Biomarker changes

    Time frame: 12 months

    NT-proBNP decrease

  3. Symptomes

    Time frame: 12 months

    NYHA change

  4. Qulaity of Life

    Time frame: 12 months

    KCCQ change

  5. All-cause mortality or HF hospitalisation

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Semmelweis University Heart and Vascular Center

Other

Collaborators

  • Laser Light Medical Innovations Ltd.

Registry information

Acronym: LASER

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

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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