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Completed

NCT Number: NCT05141175

Tailored to You (TTY) 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Primary Care

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Hypertension medication algorithm

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

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

Primary outcomes

  1. Number of Participants Enrolled as Measured by Enrollment Logs

    Time frame: 1.5 months

  2. Number of Participants That Completed Study as Measured by Enrollment Logs

    Time frame: 1.5 months

Secondary outcomes

  1. Change in Blood Pressure as Measured by Medical Record

    Time frame: Baseline, 4 months

  2. Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review

    Time frame: Up to 4 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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