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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photobiomodulation | Experimental | 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. |
|
| Sham Photobiomodulation | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Photobiomodulation | Device | Vascular photobiomodulation therapy applied over the radial artery using a red laser (wavelength: 660 nm; power: 100 mW). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brachial Artery Vascular Function | Flow-mediated dilation (FMD, %) of the brachial artery assessed by Doppler ultrasound. Higher values indicate better endothelial function | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 4 weeks |
| Acute Change in Brachial Artery Vascular Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celso Muniz, MD | Contact | +55 11 98369-6696 | freitas_celso@uol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Raphael Dias, PhD | University of Nove de Julho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raphael Dias | São Paulo | São Paulo | 01525-000 | Brazil |
We plan to share the protocol and data after the completion of the study
The protocol will be submitted briefly The data will be shared after the publication of the main results of the study
It will be open
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Sham Photobiomodulation | Device | Laser emission will be blocked to ensure no therapeutic effect |
|
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 |
| 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. | 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. | Baseline and 4 weeks |
| Change in Resting Heart Rate | Heart rate (beats per minute) measured under resting conditions using validated device | Baseline and 4 weeks |