PhotobiomoduLation for pAtientS With Advanced hEart failuRe (LASER)

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 Overview

• Status: Not yet recruiting
• Conditions: Heart Failure, Systolic; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Device: Photobiomodulation

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Photobiomodulation with active device	Device: Photobiomodulation; Soft laser therapy
Sham Comparator: Control with Sham device	Device: Photobiomodulation; Soft laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiographic response	At least 15% reduction of end-systolic volume	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other echocardiographic response	strain alanysis, LVEF, EDV, ESV	12 months
Biomarker changes	NT-proBNP decrease	12 months
Symptomes	NYHA change	12 months
Qulaity of Life	KCCQ change	12 months
All-cause mortality or HF hospitalisation		12 months

Collaborators and Investigators

• Sponsor: Semmelweis University Heart and Vascular Center
• Collaborators: Laser Light Medical Innovations Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Heart Failure, Systolic
• Other Study ID Numbers: SE-CVC-Laser 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No