Tailored to You (TTY) Pilot Study

NCT ID: NCT05141175

Last Updated: 2023-05-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2022-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Hypertension patients

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.

Group Type EXPERIMENTAL

Hypertension medication algorithm

Intervention Type DEVICE

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

Intervention Type DEVICE

The ICG system provides a printed report that indicates whether a person's hemodynamic state is predominantly one that is vasoconstricted, hyperdynamic, or mixed

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Viera, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Primary Care

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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Pro00109188

Identifier Type: -

Identifier Source: org_study_id

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