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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Soft laser therapy
Echocardiographic response
At least 15% reduction of end-systolic volume
Time frame: 12 months
Other echocardiographic response
strain alanysis, LVEF, EDV, ESV
Time frame: 12 months
Biomarker changes
NT-proBNP decrease
Time frame: 12 months
Symptomes
NYHA change
Time frame: 12 months
Qulaity of Life
KCCQ change
Time frame: 12 months
All-cause mortality or HF hospitalisation
Time frame: 12 months
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