Photobiomodulation Effects on Blood Pressure and Vascular Function in Treated Hypertensive Patients
80 patients around the world
Available in Brazil
This is a double-blind, parallel-group, randomized, sham-controlled clinical trial. A
total of 80 hypertensive patients under stable treatment with losartan (100 mg/day for at
least two months) will be recruited and randomly allocated (1:1) to one of the following
groups:
- Photobiomodulation Group;
- Sham Control Group.
The intervention will last 4 weeks, with two sessions per week, totaling 8 sessions. Each
session will last 30 minutes.
The photobiomodulation intervention will consist of laser irradiation applied over the
radial artery using a red laser (wavelength: 660 nm; power: 100 mW; duration: 30 minutes
per session; total energy: 180 J per session). The sham group will undergo an identical
procedure; however, the laser emission will be blocked to ensure no therapeutic effect.
Blinding will be maintained for all participants and outcome assessors, with only the
technician responsible for device setup aware of group allocation.
Assessments will be conducted at the following time points:
- Before and after the first intervention session (acute effects);
- Before and after the final intervention session (chronic effects).
Outcome measures will include:
- Blood pressure: office blood pressure (systolic and diastolic) measured using
validated automated devices, and residential blood pressure monitoring throughout
the study period using standardized protocols.
- Vascular function: endothelial function assessed by brachial artery flow-mediated
dilation using Doppler ultrasound, following established guidelines.
Additional measures:
- Heart rate at rest and during assessments.
This study is designed as a feasibility trial to explore the potential synergistic
effects of vascular photobiomodulation combined with losartan therapy in hypertensive
patients without major comorbidities.
University of Nove de Julho
80Patients around the world
This study is for people with
Arterial hypertension
Requirements for the patient
To 65 Years
All Gender
Medical requirements
Patient in use of losartan at a dose of 100 mg/day divided into two doses as the only antihypertensive medication, for a minimum of 2 months.
Present systolic blood pressure is less than or equal to 140 mmHg and diastolic less than or equal to 90 mmHg.
Not having used any other antihypertensive medication in the last 2 months.
Age between 18 and 65 years.
If female, not pregnant.
No cutaneous/subcutaneous lesions on both arms.
No musculoskeletal, rheumatic, cardiovascular, metabolic, neurological, oncological, immunological, hematological, psychiatric or cognitive diagnoses and that may be worsened by the intervention or prevent the correct application of FBM vascular.