An interventional study of Vascular Photobiomodulation and Sham Photobiomodulation in Hypertension, sponsored by University of Nove de Julho. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
This double-blind, randomized, sham-controlled clinical trial aims to evaluate the effects of vascular photobiomodulation on blood pressure and vascular function in hypertensive patients treated with losartan. A total of 80 patients using losartan (100 mg/day for at least two months) will be recruited and followed for 4 weeks. Participants will be randomly allocated to either an active photobiomodulation group or a sham control group.
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:
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:
Outcome measures will include:
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
Participants will receive vascular photobiomodulation therapy applied over the radial artery using a red laser (wavelength: 660 nm; power: 100 mW). Each session will last 30 minutes, with a total energy delivery of 180 J per session. Sessions will be performed twice per week for 4 weeks.
Device: Vascular Photobiomodulation
Participants will undergo an identical procedure to the experimental group; however, the laser emission will be blocked to ensure no therapeutic effect. All procedures, duration, and frequency will be identical to the experimental group to maintain blinding.
Device: Sham Photobiomodulation
Vascular photobiomodulation therapy applied over the radial artery using a red laser (wavelength: 660 nm; power: 100 mW).
Laser emission will be blocked to ensure no therapeutic effect
Change in Brachial Artery Vascular Function
Flow-mediated dilation (FMD, %) of the brachial artery assessed by Doppler ultrasound. Higher values indicate better endothelial function
Time frame: Baseline and 4 weeks
Change in Resting Systolic and Diastolic Blood Pressure
Systolic and diastolic blood pressure (mmHg) measured under standardized resting conditions using validated automated devices. Lower values indicate improvement
Time frame: Baseline and 4 weeks
Acute Change in Brachial Artery Vascular Function
Flow-mediated dilation (FMD, %) of the brachial artery assessed by Doppler ultrasound before and after the intervention session, following current guidelines. Higher values indicate better endothelial function
Time frame: Baseline and 4 weeks
Acute Change in Resting Blood Pressure
Systolic and diastolic blood pressure (mmHg) measured immediately before and after the intervention session using validated automated devices.
Time frame: Baseline and 4 weeks
Change in Residential Blood Pressure
Mean systolic and diastolic blood pressure (mmHg) obtained during one week through residential blood pressure monitoring using validated devices and standardized protocols across the intervention period. Lower values indicate improvement.
Time frame: Baseline and 4 weeks
Change in Resting Heart Rate
Heart rate (beats per minute) measured under resting conditions using validated device
Time frame: Baseline and 4 weeks
Plan to share: Yes — We plan to share the protocol and data after the completion of the study
Supporting information: Study protocol, Statistical analysis plan
Time frame: The protocol will be submitted briefly The data will be shared after the publication of the main results of the study
Access criteria: It will be open
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