Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501313
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
PhotobiomoduLation for pAtientS With Advanced hEart failuRe
Sponsor:
Semmelweis University Heart and Vascular Center
Organization:
Semmelweis University Heart and Vascular Center
Study Overview
Official Title:
PhotobiomoduLation for pAtientS With Advanced hEart failuRe
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LASER
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None