Photobiomodulation Effects on Blood Pressure and Vascular Function in Treated Hypertensive Patients

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Nove de Julho

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Changes in medication status during the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vascular Photobiomodulation

    Device

    Vascular photobiomodulation therapy applied over the radial artery using a red laser (wavelength: 660 nm; power: 100 mW).

  • Sham Photobiomodulation

    Device

    Laser emission will be blocked to ensure no therapeutic effect

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: PhotobiomodulationExperimental treatment 1 intervention
Group B: Sham PhotobiomodulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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