Tailored to You (TTY) Pilot Study

NCT05141175 | Completed Results FDA Device

• 1 other identifier: Pro00109188
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Number of Participants Enrolled as Measured by Enrollment Logs

  1.5 months

• Number of Participants That Completed Study as Measured by Enrollment Logs

  1.5 months

Secondary Outcomes (2)

• Change in Blood Pressure as Measured by Medical Record

  Baseline, 4 months

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

  Up to 4 months

Study Arms (1)

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.

Device: Hypertension medication algorithm; Device: Impedance Cardiography

Interventions

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.

Hypertension patients

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

Hypertension patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Primary Care

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Cardiography, Impedance

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Plethysmography, Impedance; Plethysmography

Results Point of Contact

• Title: Dr. Anthony Viera
• Organization: Duke University

anthony.viera@duke.edu

919 681 3178

Study Officials

• Anthony Viera, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 2, 2021
• Study Start: January 10, 2022
• Primary Completion: March 1, 2022
• Study Completion: June 28, 2022
• Last Updated: May 1, 2023
• Results First Posted: May 1, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)