HypertensionNCT07525310
Photobiomodulation Effects on Blood Pressure and Vascular Function in Treated Hypertensive Patients
A study testing Vascular Photobiomodulation in people with Hypertension, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Vascular Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be taking losartan at a dose of 100 mg/day, either as monotherapy or in combination with other antihypertensive medications, administered in two divided doses, for a minimum of 2 months and a maximum of 24 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.
Who cannot join
- Changes in medication status during the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Raphael Dias
São Paulo, São Paulo, 01525-000
Celso Muniz, MD, +55 11 98369-6696, freitas_celso@uol.com.br
About this study
Official title: Effect of Vascular Photobiomodulation on Cardiovascular Parameters of Treated Hypertensive Patients: A Randomized and Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- Vascular Photobiomodulation, Sham Photobiomodulation
- Keywords
- Vascular Photobiomodulation, Blood pressure, Vascular function
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular PhotobiomodulationDevice
Vascular photobiomodulation therapy applied over the radial artery using a red laser (wavelength: 660 nm; power: 100 mW).
Sham PhotobiomodulationDevice
Laser emission will be blocked to ensure no therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vascular Photobiomodulation |
| 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. Receives: Device: Sham Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brachial Artery Vascular Function
Flow-mediated dilation (FMD, %) of the brachial artery assessed by Doppler ultrasound. Higher values indicate better endothelial function
Measured: Baseline and 4 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks
Change in Resting Heart Rate
Heart rate (beats per minute) measured under resting conditions using validated device
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Sep 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Mendes Ritti Dias, University of Nove de Julho
- Investigators
- Raphael Dias, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07525310
- Sponsor's protocol ID
- PBM-Hypertension-RCT-2026
- Status last verified
- Sep 2026
- First submitted
- 6 Apr 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the protocol and data after the completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vascular Photobiomodulation on Cardiovascular Parameters of Treated Hypertensive Patients: A Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07525310
- Acronym / sponsor ID
- PBM-Hypertension-RCT-2026
- Conditions
- Hypertension
- Keywords
- Vascular Photobiomodulation, Blood pressure, Vascular function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: Vascular PhotobiomodulationParticipants 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 | Device: Sham PhotobiomodulationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be taking losartan at a dose of 100 mg/day, either as monotherapy or in combination with other antihypertensive medications, administered in two divided doses, for a minimum of 2 months and a maximum of 24 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
Key exclusion criteria (1 listed)
- Changes in medication status during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular PhotobiomodulationVascular photobiomodulation therapy applied over the radial artery using a red laser (wavelength: 660 nm; power: 100 mW). | Device | Photobiomodulation |
| Sham PhotobiomodulationLaser emission will be blocked to ensure no therapeutic effect | Device | Sham Photobiomodulation |
Primary outcome
Change in Brachial Artery Vascular Function
Time frame: Baseline and 4 weeks
Flow-mediated dilation (FMD, %) of the brachial artery assessed by Doppler ultrasound. Higher values indicate better endothelial function
5 secondary outcomes
Change in Resting Systolic and Diastolic Blood Pressure
Time frame: Baseline and 4 weeks
Acute Change in Brachial Artery Vascular Function
Time frame: Baseline and 4 weeks
Acute Change in Resting Blood Pressure
Time frame: Baseline and 4 weeks
Change in Residential Blood Pressure
Time frame: Baseline and 4 weeks
Change in Resting Heart Rate
Time frame: Baseline and 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. We plan to share the protocol and data after the completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raphael Dias, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular Photobiomodulation in people with Hypertension, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Celso Muniz, MD (+55 11 98369-6696, freitas_celso@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brachial Artery Vascular Function (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.