PhotobiomoduLation for pAtientS With Advanced hEart failuRe

NCT06501313 | Not Yet Recruiting DMC

• 1 other identifier: SE-CVC-Laser 1.0
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure With Reduced Ejection Fraction; Heart Failure, Systolic

Outcome Measures

Primary Outcomes (1)

• Echocardiographic response

  At least 15% reduction of end-systolic volume

  12 months

Secondary Outcomes (5)

• Other echocardiographic response

  12 months

• Biomarker changes

  12 months

• Symptomes

  12 months

• Qulaity of Life

  12 months

• All-cause mortality or HF hospitalisation

  12 months

Study Arms (2)

Photobiomodulation with active device

ACTIVE COMPARATOR

Device: Photobiomodulation

Control with Sham device

SHAM COMPARATOR

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

Soft laser therapy

Control with Sham device; Photobiomodulation with active device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced-stage HFrEF patients who were ineligible for heart transplantation Patients over 18 years of age The expected lifespan exceeds 1 year Consent form

You may not qualify if:

• Non-compliant patient Pregnant women Drug or alcohol abuse The patient is participating in another clinical trial

Sponsors & Collaborators

• Semmelweis University Heart and Vascular Center: lead
• Laser Light Medical Innovations Ltd.: collaborator

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective, double-blind, randomized

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: August 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: May 1, 2026
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share