PhotobiomoduLation for pAtientS With Advanced hEart failuRe

Not Applicable

Not yet recruiting

• Conditions: Heart Failure, Systolic; Heart Failure With Reduced Ejection Fraction
• Interventions: Device: Photobiomodulation

• Registration Number: NCT06501313
• Lead Sponsor: Semmelweis University Heart and Vascular Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Study Start: 2024-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control with Sham device	Photobiomodulation	-
Photobiomodulation with active device	Photobiomodulation	-

Primary Outcome Measures

Name	Time	Method
Echocardiographic response	12 months	At least 15% reduction of end-systolic volume

Secondary Outcome Measures

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