Aortic Dissection, Hypertension
Conditions
Keywords
Withings Blood Pressure Monitor, Heart Rate, Ambulatory Blood Pressure
Brief summary
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
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).
Interventions
DEVICEWithings Digital Blood Pressure Monitor
This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure at End of 4 Weeks | 4 weeks | Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Intervention | 4 weeks | Surgical intervention (open or endovascular) |
| Hospitalization or Emergency Room Visit for Uncontrolled Hypertension or Symptoms From Dissection | 4 weeks | Individual occurrence of hospitalization or Emergency Room visit for uncontrolled hypertension or symptoms from dissection |
| Mortality | 4 weeks | Individual incidence of death |
| Increase in Size or Progression of Dissection as Measured on Cardiac CT | 4 weeks | Incidence of Increase in size or progression of dissection compared to baseline as measured on cardiac CT |
| Questionnaire Describing Patient Experience in the Study | 4 weeks | Collection of answers to questionnaire describing patient experience in the study |
| Hospitalization or Emergency Room Visit for Hypotension | 4 weeks | Individual occurrence of hospitalization or Emergency Room visit for Hypotension |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 1 |
| 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. | 3 |
| Total | 4 |
Baseline characteristics
| Characteristic | Intervention Group (Digital BP Monitoring) | Standard of Care BP Monitoring | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 3 | 0 / 1 |
Outcome results
Primary
Systolic Blood Pressure at End of 4 Weeks
Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff.
Time frame: 4 weeks
Population: Study terminated prematurely due to COVID-19 pandemic; no analysis was performed.
Secondary
Hospitalization or Emergency Room Visit for Hypotension
Individual occurrence of hospitalization or Emergency Room visit for Hypotension
Time frame: 4 weeks
Population: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
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
Time frame: 4 weeks
Population: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
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
Time frame: 4 weeks
Population: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Secondary
Mortality
Individual incidence of death
Time frame: 4 weeks
Population: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Secondary
Questionnaire Describing Patient Experience in the Study
Collection of answers to questionnaire describing patient experience in the study
Time frame: 4 weeks
Population: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Secondary
Surgical Intervention
Surgical intervention (open or endovascular)
Time frame: 4 weeks
Population: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.