HypertensionCATCH-USNCT06721611
A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.
An observational study of Hypertension, run by Nucor at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Optical Blood Pressure Monitoring Device (Aktiia G1)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 100 subjects aged 25 to 70 years old who do not have a known diagnosis of hypertension and are employed at the Nucor Corp facility.
Who may be able to join
- Adult subjects aged 25 to 70 years old.
- People who self-report that they do not have a diagnosis of hypertension.
- People employed as a Nucor team member.
- People who can read and speak English.
- People who use either an iOS or Android smart phone.
- Subjects who agree to follow study procedures.
- Subjects who have signed the informed consent form.
Who cannot join
- 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.
- Subjects who take insulin.
- Subjects who are on hemodialysis.
- Women who are known to be pregnant.
- Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
- Subjects who do not have two arms.
- Subjects with upper arm circumference < 22cm or > 42cm.
- Subjects with wrist circumference > 23cm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.: a Prospective Single-center Observational Clinical Study.
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).
Read the 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.
- Conditions
- Hypertension
- Being tested
- Optical Blood Pressure Monitoring Device (Aktiia G1)
- Keywords
- hypertension, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Blood Pressure Monitoring Device (Aktiia G1)Device
Non-hypertensive Nucor employees that accept to wear an optical blood pressure monitoring device (Aktiia 24/7 device) to screen for and identify potential undiagnosed hypertension.
100 participants. Each participant will wear the device continuously for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| CATCH-US cohort | Non-hypertensive Nucor employees that accept to receive and wear continuously for 28 days an optical blood pressure monitoring device (Aktiia 24/7 device) Receives: Device: Optical Blood Pressure Monitoring Device (Aktiia G1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects with undiagnosed hypertension
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.
Measured: Each participant will wear the device continuously for 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start16 Jan 2025 (estimated)
- Primary completion16 Jul 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Why it stopped: The study was aborted by the sponsor.
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nucor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06721611
- Sponsor's protocol ID
- CATCH-US
- Acronym
- CATCH-US
- Status last verified
- Feb 2025
- First submitted
- 3 Dec 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Optical Blood Pressure Assessment Tool to Identify Cases of Unscreened Hypertension Across an Active Population in the U.S.: a Prospective Single-center Observational Clinical Study.
- ClinicalTrials.gov ID
- NCT06721611
- Acronym / sponsor ID
- CATCH-US / CATCH-US
- Conditions
- Hypertension
- Keywords
- hypertension, blood pressure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was aborted by the sponsor.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NucorIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2025 (estimated)
- Primary completion
- 16 Jul 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 6 Dec 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CATCH-US cohort | – | Device: Optical Blood Pressure Monitoring Device (Aktiia G1)Non-hypertensive Nucor employees that accept to receive and wear continuously for 28 days an optical blood pressure monitoring device (Aktiia 24/7 device) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 100 subjects aged 25 to 70 years old who do not have a known diagnosis of hypertension and are employed at the Nucor Corp facility.
Key inclusion criteria (7 listed)
- Adult subjects aged 25 to 70 years old.
- People who self-report that they do not have a diagnosis of hypertension.
- People employed as a Nucor team member.
- People who can read and speak English.
- People who use either an iOS or Android smart phone.
Key exclusion criteria (8 listed)
- 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.
- Subjects who take insulin.
- Subjects who are on hemodialysis.
- Women who are known to be pregnant.
- Subjects whose arms shake uncontrollably or are paralyzed (cannot move).
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 |
|---|---|---|
| Optical Blood Pressure Monitoring Device (Aktiia G1)Non-hypertensive Nucor employees that accept to wear an optical blood pressure monitoring device (Aktiia 24/7 device) to screen for and identify potential undiagnosed hypertension. 100 participants. Each participant will wear the device continuously for 28 days. | Device | CATCH-US cohort |
Primary outcome
The percentage of subjects with undiagnosed hypertension
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Nucor at 1 site in United States.
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 8 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: withdrawn, as of the sponsor's last update on 6 Feb 2025. 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 United States. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects with undiagnosed hypertension (time frame: Each participant will wear the device continuously for 28 days.). 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 6 Feb 2025.