A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.

Withdrawn

• Conditions: Hypertension

• Registration Number: NCT06721611
• Lead Sponsor: Nucor

Brief Summary

To screen for and identify subjects with potential undiagnosed hypertension using an optical blood pressure monitoring device across an active workforce population in the US (Nucor employees).

Detailed Description

100 voluntary Nucor facility employees with no previous diagnosis of hypertension will be recruited and will receive an optical blood pressure monitoring device (Aktiia G1 Device) that is a miniature bracelet placed in the wrist and measure blood pressure continuously without inflating.

Each participant will wear the device continually during 28 days.

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Study Start: 2025-01-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06
• Primary Completion: 2025-07-16
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Adult subjects aged 25 to 70 years old.
2. People who self-report that they do not have a diagnosis of hypertension.
3. People employed as a Nucor team member.
4. People who can read and speak English.
5. People who use either an iOS or Android smart phone.
6. Subjects who agree to follow study procedures.
7. Subjects who have signed the informed consent form.

Exclusion Criteria

1. Subjects with a known diagnosis of i. atrial fibrillation ii. congestive heart failure iii. heart valve disease iv. pheochromocytoma v. Raynaud's disease vi. arm lymphedema.
2. Subjects who take insulin.
3. Subjects who are on hemodialysis.
4. Women who are known to be pregnant.
5. Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
6. Subjects who do not have two arms.
7. Subjects with upper arm circumference < 22cm or > 42cm.
8. Subjects with wrist circumference > 23cm.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with undiagnosed hypertension	Each participant will wear the device continuously for 28 days.	Analysis of the percentage of subjects with undiagnosed hypertension defined as an average daytime SBP\>130 or DBP\>80 mmHg over the initial 7 days of the Aktiia 24/7 device use.

Trial Locations

Locations (1)

Nucor; 🇺🇸 Charlotte, North Carolina, United States