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Difficulty with patient enrollment and carrying out the study logistics due to COVID-19
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The primary objective of this study is to determine the effectiveness of home digital blood pressure monitoring in aiding providers to maintain blood pressure within a therapeutic range in type B aortic dissection patients upon discharge from the hospital.
Patients admitted to the Cleveland Clinic Main Campus with a diagnosis of type B aortic dissection or intramural hematoma who do not receive a surgical intervention during their index hospitalization, or planned intervention on follow up, and are discharged on medical therapy consisting of strict heart rate control and BP control will be included in the study. They will be either randomized to standard therapy to measure BP at home (standard of care) or intervention arm consisting of Withings Wireless Blood Pressure Monitor, which will transmit BP recordings from smartphone to MyChart/EPIC (test arm). All patients will first receive a 24 hour ambulatory monitor regardless of treatment assignment to establish baseline BP pattern. Following this patients randomized to intervention arm will utilize their Withings Blood Pressure Monitor. Providers on the study team will then adjust the patient's hypertensive medications to ensure their BP is below a systolic goal of 120 mmHg utilizing downloaded recordings available in the electronic medical record.
The primary clinical endpoint is the change in mean 24 hour systolic blood pressure between the start of the study and the end of the study period (4-week period). Secondary outcomes will include the number of patients able to achieve a therapeutic systolic blood pressure of 120 mmHg with both mean BP cuff and in office visit at end of 4 week period, increase in size as measured by computed tomography (CT) scan of the aorta, hospitalization or emergency room (ER) visits for symptoms from dissection or uncontrolled hypertension, hospitalization or ER visits for hypotension, all-cause mortality, and need for surgical intervention (open or endovascular).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (digital BP monitoring) | Experimental | This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. |
|
| Standard of care BP monitoring | No Intervention | This group will use a standard BP cuff and record and transmit data to their medical team as instructed by their providers or if they are concerned. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Withings Digital Blood Pressure Monitor | Device | This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure at End of 4 Weeks | Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Individual incidence of death | 4 weeks |
| Surgical Intervention | Surgical intervention (open or endovascular) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Venugopal Menon, M. D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care BP Monitoring | This group will use a standard BP cuff and record and transmit data to their medical team as instructed by their providers or if they are concerned. |
| FG001 | Intervention Group (Digital BP Monitoring) | This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group (Digital BP Monitoring) | This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone. |
| BG001 |
| 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 | Systolic Blood Pressure at End of 4 Weeks | Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff. | Study terminated prematurely due to COVID-19 pandemic; no analysis was performed. | Posted | 4 weeks |
|
2 weeks and 4 weeks
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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 | Standard of Care BP Monitoring | This group will use a standard BP cuff and record and transmit data to their medical team as instructed by their providers or if they are concerned. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Venu Menon, M. D. | Cleveland Clinic | 216-445-5390 | menonv@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2019 | Feb 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000784 | Aortic Dissection |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D000094665 | Dissection, Blood Vessel |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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50 patients will be randomly assigned to standard of care home blood pressure monitoring while the other 50 patients will be randomized to Withings home digital blood pressure monitoring.
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| Hospitalization or Emergency Room Visit for Uncontrolled Hypertension or Symptoms From Dissection | Individual occurrence of hospitalization or Emergency Room visit for uncontrolled hypertension or symptoms from dissection | 4 weeks |
| Hospitalization or Emergency Room Visit for Hypotension | Individual occurrence of hospitalization or Emergency Room visit for Hypotension | 4 weeks |
| Increase in Size or Progression of Dissection as Measured on Cardiac CT | Incidence of Increase in size or progression of dissection compared to baseline as measured on cardiac CT | 4 weeks |
| Questionnaire Describing Patient Experience in the Study | Collection of answers to questionnaire describing patient experience in the study | 4 weeks |
| Standard of Care BP Monitoring |
This group will use a standard BP cuff and record and transmit data to their medical team as instructed by their providers or if they are concerned. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
| Secondary | Mortality | Individual incidence of death | Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed. | Posted | 4 weeks |
|
|
| Secondary | Surgical Intervention | Surgical intervention (open or endovascular) | Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed. | Posted | 4 weeks |
|
|
| Secondary | Hospitalization or Emergency Room Visit for Uncontrolled Hypertension or Symptoms From Dissection | Individual occurrence of hospitalization or Emergency Room visit for uncontrolled hypertension or symptoms from dissection | Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed. | Posted | 4 weeks |
|
|
| Secondary | Hospitalization or Emergency Room Visit for Hypotension | Individual occurrence of hospitalization or Emergency Room visit for Hypotension | Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed. | Posted | 4 weeks |
|
|
| Secondary | Increase in Size or Progression of Dissection as Measured on Cardiac CT | Incidence of Increase in size or progression of dissection compared to baseline as measured on cardiac CT | Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed. | Posted | 4 weeks |
|
|
| Secondary | Questionnaire Describing Patient Experience in the Study | Collection of answers to questionnaire describing patient experience in the study | Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed. | Posted | 4 weeks |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Intervention Group (Digital BP Monitoring) | This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D000094683 |
| Acute Aortic Syndrome |
| D001018 | Aortic Diseases |