Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients

Conditions
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Aortic Dissection, Hypertension

Intervention / Treatment
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* Device: Withings Digital Blood Pressure Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients discharged from Cleveland Clinic Main Campus with principal diagnosis of type B aortic dissection (defined as distal from left subclavian artery) who do not receive a surgical intervention during their hospitalization Arm Circumference of 9-17 inches Exclusion Criteria: Patients who do not have a smart phone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group (digital BP monitoring)<br>This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. | Device: Withings Digital Blood Pressure Monitor<br>* This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.<br>|
| No Intervention: Standard of care BP monitoring<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Individual incidence of death | 4 weeks | 
| Surgical Intervention | Surgical intervention (open or endovascular) | 4 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Withings Blood Pressure Monitor, Heart Rate, Ambulatory Blood Pressure