PhotobiomoduLation for pAtientS With Advanced hEart failuRe

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06501313

Acronym

LASER

Enrollment

Registered

2024-07-15

Start date

2024-08-01

Completion date

2026-05-01

Last updated

2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Systolic, Heart Failure With Reduced Ejection Fraction

Brief 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.

Interventions

DEVICEPhotobiomodulation

Soft laser therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

prospective, double-blind, randomized

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026