PhotobiomoduLation for pAtientS With Advanced hEart failuRe | NCT06501313

Studies
PhotobiomoduLation for pAtientS With Advanced hEart failuRe

NCT06501313

Sponsor

Semmelweis University Heart and Vascular Center

Status

Not yet recruiting

Last Update Posted

Jul 15, 2024Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Heart Failure With Reduced Ejection Fraction
Heart Failure, Systolic

Interventions

Photobiomodulation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Estimated

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

May 1, 2026Estimated

First Submitted Date

Jul 8, 2024

First Submission Date that Met QC Criteria

Jul 8, 2024

First Posted Date

Jul 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2024

Last Update Posted Date

Jul 15, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annamaria Kosztin MD, PhD, Principal Investigator, Semmelweis University Heart and Vascular CenterPrincipal Investigator

Lead Sponsor

Semmelweis University Heart and Vascular CenterOTHER

Collaborators

Name	Class
Laser Light Medical Innovations Ltd.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Photobiomodulation with active device	Active Comparator		Device: Photobiomodulation
Control with Sham device	Sham Comparator		Device: Photobiomodulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Photobiomodulation	Device	Soft laser therapy	Control with Sham device Photobiomodulation with active device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Echocardiographic response	At least 15% reduction of end-systolic volume	12 months

Secondary Outcomes

Measure	Description	Time Frame
Other echocardiographic response	strain alanysis, LVEF, EDV, ESV	12 months
Biomarker changes	NT-proBNP decrease	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054143	Heart Failure, Systolic

Ancestor Terms

ID	Term
D006333	Heart Failure
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D028022	Low-Level Light Therapy

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy

Browse Leaves

Not provided

Browse Branches

Not provided