NCT06501313

PhotobiomoduLation for pAtientS With Advanced hEart failuRe

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Semmelweis University Heart and Vascular Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Photobiomodulation	Soft laser therapy

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-12-31
• Completion: 2026-05-01
• First posted: 2024-07-15
• Last updated: 2024-07-15