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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Viera, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Primary Care | Durham | North Carolina | 27705 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Enrolled as Measured by Enrollment Logs | Posted | Count of Participants | Participants | 1.5 months |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anthony Viera | Duke University | 919 681 3178 | anthony.viera@duke.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2022 | Mar 27, 2023 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D002307 | Cardiography, Impedance |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 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 |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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| Primary | Number of Participants That Completed Study as Measured by Enrollment Logs | Posted | Count of Participants | Participants | 1.5 months |
|
|
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| Secondary | Change in Blood Pressure as Measured by Medical Record | Posted | Mean | Standard Deviation | mmHg | Baseline, 4 months |
|
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| Secondary | Number of Anti-hypertensive Medications Prescribed as Measured by Medical Record Review | Posted | Mean | Standard Deviation | anti-hypertensive medications | Up to 4 months |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D010992 | Plethysmography, Impedance |
| D010991 | Plethysmography |