PhotobiomoduLation for pAtientS With Advanced hEart failuRe

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure With Reduced Ejection Fraction Heart Failure, Systolic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

prospective, double-blind, randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Photobiomodulation with active device

Group Type ACTIVE_COMPARATOR

Photobiomodulation

Intervention Type DEVICE

Soft laser therapy

Control with Sham device

Group Type SHAM_COMPARATOR

Photobiomodulation

Intervention Type DEVICE

Soft laser therapy

Interventions

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