HypertensionNCT05141175
Tailored to You (TTY) Pilot Study
A study testing Hypertension medication algorithm and Impedance Cardiography in people with Hypertension, run by Duke University at 1 site in United States.
Trial summary
The purpose of this research study is to use a test called impedance cardiography (ICG) to provide more information about how to improve the control of blood pressure. Participants will be given this test so investigators can get more information about what is going on inside the heart and blood vessels that is… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Hypertension medication algorithm and Impedance Cardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 28 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of hypertension
- Most recent office systolic BP average measured using automated office BP (AOBP) is ≥140 mmHg systolic or ≥90 mmHg diastolic
- Currently prescribed at least one BP-lowering medication
- Under the care of a primary care clinician
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Duke Primary Care Tailored to You (TTY) Blood Pressure Control Pilot Study
The purpose of this research study is to use a test called impedance cardiography (ICG) to provide more information about how to improve the control of blood pressure. Participants will be given this test so investigators can get more information about what is going on inside the heart and blood vessels that is contributing to high blood pressure. ICG is a lot like an EKG (electrocardiogram) in that it uses electrodes and a computer to make a report. Participants will lie down on the exam table and two electrodes go on the right ankle and two electrodes go on the left wrist. The process takes about 5 minutes and is painless and not invasive.
- Conditions
- Hypertension
- Being tested
- Hypertension medication algorithm, Impedance Cardiography
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertension medication algorithmDevice
The algorithm is configured to align medication choices based on the hemodynamic findings from the ICG readings. This decision support tool was created so as to organize these medications based on their mechanism of action and is consistent with the evidence-based treatment of hypertension.
Impedance CardiographyDevice
The ICG system provides a printed report that indicates whether a person's hemodynamic state is predominantly one that is vasoconstricted, hyperdynamic, or mixed
| Study group | Role | What they receive |
|---|---|---|
| Hypertension patients | Experimental | Patients with documented diagnosis of hypertension and their most recent office systolic BP average measured using automated office BP is ≥140 mmHg systolic or ≥90 mmHg diastolic and they are currently prescribed at least one BP-lowering medication will be recruited. Receives: Device: Hypertension medication algorithm; Device: Impedance Cardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled as Measured by Enrollment Logs
Measured: 1.5 months
Number of Participants That Completed Study as Measured by Enrollment Logs
Measured: 1.5 months
Secondary outcomes (2)
Change in Blood Pressure as Measured by Medical Record
Measured: Baseline, 4 months
Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start10 Jan 2022
- Primary completion1 Mar 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Viera, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141175
- Sponsor's protocol ID
- Pro00109188
- Status last verified
- Mar 2023
- First submitted
- 15 Nov 2021
- Last updated
- 1 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Duke Primary Care Tailored to You (TTY) Blood Pressure Control Pilot Study
- ClinicalTrials.gov ID
- NCT05141175
- Acronym / sponsor ID
- Pro00109188
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Posted 1 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to use a test called impedance cardiography (ICG) to provide more information about how to improve the control of blood pressure. Participants will be given this test so investigators can get more information about what is going on inside the heart and blood vessels that is contributing to high blood pressure. ICG is a lot like an EKG (electrocardiogram) in that it uses electrodes and a computer to make a report. Participants will lie down on the exam table and two electrodes go on the right ankle and two electrodes go on the left wrist. The process takes about 5 minutes and is painless and not invasive.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertension patients | Experimental | Device: Hypertension medication algorithm, Device: Impedance CardiographyPatients with documented diagnosis of hypertension and their most recent office systolic BP average measured using automated office BP is ≥140 mmHg systolic or ≥90 mmHg diastolic and they are currently prescribed at least one BP-lowering medication will be recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented diagnosis of hypertension
- Most recent office systolic BP average measured using automated office BP (AOBP) is ≥140 mmHg systolic or ≥90 mmHg diastolic
- Currently prescribed at least one BP-lowering medication
- Under the care of a primary care clinician
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Hypertension medication algorithmThe algorithm is configured to align medication choices based on the hemodynamic findings from the ICG readings. This decision support tool was created so as to organize these medications based on their mechanism of action and is consistent with the evidence-based treatment of hypertension. | Device | Hypertension patients |
| Impedance CardiographyThe ICG system provides a printed report that indicates whether a person's hemodynamic state is predominantly one that is vasoconstricted, hyperdynamic, or mixed | Device | Hypertension patients |
Primary outcome
Number of Participants Enrolled as Measured by Enrollment Logs
Time frame: 1.5 months
Number of Participants That Completed Study as Measured by Enrollment Logs
Time frame: 1.5 months
2 secondary outcomes
Change in Blood Pressure as Measured by Medical Record
Time frame: Baseline, 4 months
Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review
Time frame: Up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Anthony Viera, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertension medication algorithm and Impedance Cardiography in people with Hypertension, run by Duke University 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 4 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: finished, as of the sponsor's last update on 1 May 2023. 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?
Yes. Results are posted in the registry (first posted 1 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Enrolled as Measured by Enrollment Logs (time frame: 1.5 months). The study lists 2 primary outcomes in all. 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 1 May 2023.