photobiomodulation therapy(low level LASER therapy) in heart failure

Phase 3

Recruiting

Conditions: Heart failure reduced ejection fraction.
Heart failure

Registration Number: IRCT20191207045638N1

Lead Sponsor: Islamic Azad University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Expressed readiness to comply with all study procedures and availability for the duration of the study
Provision of dated and signed informed consent form
Age 18-65 years
A diagnosis of heart failure reduced ejection fraction (LVEF= 40%) due to ischemic or non-ischemic etiology
Optimal guideline directed medical therapies including angiotensin-converting enzymeinhibitors, ß-blockers, aldosterone antagonists, and diuretics for at least 3 months
NewYork Heart association function class (NYHA Class) II-III

Exclusion Criteria

History of hospitalization for any cause including acute heart failure in preceding month
presence Chronic renal failure or dialysis
presence of chronic hepatic failure
presence of neuromuscular disorders
Presence of severe chronic pulmonary disease
The patients who have pace maker, intracardiac defibrillator (ICD)or cardiac resynchronization therapy(CRT)
psychiatric conditions
inability to perform 6 minutes walk test
Cardiomyopathy secondary to cancer therapy
Presence of any hematologic , Rheumatologic disorder

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ewYork Heart Association functional class, Physical performance( 6 minutes walk test distance). Timepoint: Before intervention and after completion of intervention. Method of measurement: 1-New York heart association(NYHA) measurement :NYHA scores range from I (no symptoms of heart failure ) to IV (symptoms at rest) 2- Physical performance of patients was assessed using the 6-minute walk test (6MWT) according to the protocol of Guyatt and colleagues.

Secondary Outcome Measures

Name	Time	Method
Serum level of N terminal pro -brain natreuretic peptide. Timepoint: before intervention and at the intervention completion. Method of measurement: enzyme immunoassay.;Quality of life. Timepoint: before intervention and at the intervention completion. Method of measurement: Iranian quality of life questionnaire (IHF-QOL).;Echocardiographic data: left ventricular ejection fraction ,Left ventircular end diastolic and systolic dimentions,left ventricular global longitudinal strain. Timepoint: before intervention and at the intervention completion. Method of measurement: Echocardiographic machine.