Hypertension
Conditions
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.
Interventions
DEVICEHypertension 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.
DEVICEImpedance 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
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Hypertension Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants Enrolled as Measured by Enrollment Logs
Time frame: 1.5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hypertension Patients | Number of Participants Enrolled as Measured by Enrollment Logs | 20 Participants |
Primary
Number of Participants That Completed Study as Measured by Enrollment Logs
Time frame: 1.5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hypertension Patients | Number of Participants That Completed Study as Measured by Enrollment Logs | 19 Participants |
Secondary
Change in Blood Pressure as Measured by Medical Record
Time frame: Baseline, 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hypertension Patients | Change in Blood Pressure as Measured by Medical Record | systolic blood pressure | 11 mmHg | Standard Deviation 7 |
| Hypertension Patients | Change in Blood Pressure as Measured by Medical Record | diastolic blood pressure | 3 mmHg | Standard Deviation 3 |
Secondary
Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review
Time frame: Up to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertension Patients | Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review | 2.60 anti-hypertensive medications | Standard Deviation 0.5 |