Clinical Trial

PhotobiomoduLation for pAtientS With Advanced hEart failuRe

Study acronym: LASER
Unknown
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Record status
This record was last updated July 15, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06501313
Lead Sponsor Semmelweis University Heart and Vascular Center
Collaborators: Laser Light Medical Innovations Ltd.
Conditions Heart Failure With Reduced Ejection Fraction, Heart Failure, Systolic
Enrollment 70 participants
Start Date 2024-08-01
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2024-07-15