PhotobiomoduLation for pAtientS With Advanced hEart failuRe
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University Heart and Vascular Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation
DeviceSoft laser therapy
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Photobiomodulation with active deviceActive comparator 1 intervention
Group B: Control with Sham deviceSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Echocardiographic response
At least 15% reduction of end-systolic volume
Time frame
12 monthsSecondary outcomes
1
Other echocardiographic response
strain alanysis, LVEF, EDV, ESV
Time frame
12 months2
Biomarker changes
NT-proBNP decrease
Time frame
12 months3
Symptomes
NYHA change
Time frame
12 months4
Qulaity of Life
KCCQ change
Time frame
12 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Semmelweis University Heart and Vascular Center
Lead sponsor
Laser Light Medical Innovations Ltd.
Collaborator
Source ClinicalTrials.gov
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