PhotobiomoduLation for pAtientS With Advanced hEart failuRe
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Primary Endpoint
- Echocardiographic response
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Echocardiographic response
Time Frame: 12 months
At least 15% reduction of end-systolic volume
Secondary Outcomes
- Other echocardiographic response(12 months)
- Biomarker changes(12 months)
- Qulaity of Life(12 months)
- Symptomes(12 months)
- All-cause mortality or HF hospitalisation(12 months)
Investigators
Annamaria Kosztin MD, PhD
Principal Investigator
Semmelweis University Heart and Vascular Center