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

NCT07525310 | Not Yet Recruiting

• 1 other identifier: PBM-Hypertension-RCT-2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension

Keywords

Vascular Photobiomodulation; Blood pressure; Vascular function

Outcome Measures

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

  Baseline and 4 weeks

Secondary Outcomes (5)

• Change in Resting Systolic and Diastolic Blood Pressure

  Baseline and 4 weeks

• Acute Change in Brachial Artery Vascular Function

  Baseline and 4 weeks

• Acute Change in Resting Blood Pressure

  Baseline and 4 weeks

• Change in Residential Blood Pressure

  Baseline and 4 weeks

• Change in Resting Heart Rate

  Baseline and 4 weeks

Study Arms (2)

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.

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.

Device: Sham Photobiomodulation

Interventions

Vascular Photobiomodulation DEVICE

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

Photobiomodulation

Sham Photobiomodulation DEVICE

Laser emission will be blocked to ensure no therapeutic effect

Sham Photobiomodulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Changes in medication status during the study

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Raphael Dias

São Paulo, São Paulo, 01525-000, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Raphael Dias, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Celso Muniz, MD

CONTACT

+55 11 98369-6696; freitas_celso@uol.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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

Locations

BR (1)