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NCT05141175 Clinical Trial

Tailored to You (TTY) Pilot Study

Hypertension Clinical Trial

Official title:
The Duke Primary Care Tailored to You (TTY) Blood Pressure Control Pilot Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05141175
Other study ID # Pro00109188
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date June 28, 2022

Study information
Verified date March 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date June 28, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Hypertension medication algorithm
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 Cardiography
The ICG system provides a printed report that indicates whether a person's hemodynamic state is predominantly one that is vasoconstricted, hyperdynamic, or mixed

Locations
Country Name City State
United States Duke Primary Care Durham North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Enrolled as Measured by Enrollment Logs 1.5 months
Primary Number of Participants That Completed Study as Measured by Enrollment Logs 1.5 months
Secondary Change in Blood Pressure as Measured by Medical Record Baseline, 4 months
Secondary Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review Up to 4 months
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