Clinical trial NCT04116684: Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients
Official title: Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Aortic Dissection
Hypertension
Keywords: Withings Blood Pressure Monitor
Heart Rate
Ambulatory Blood Pressure
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure at End of 4 Weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Mortality
timeFrame: 4 weeks
measure: Surgical Intervention
timeFrame: 4 weeks
measure: Hospitalization or Emergency Room Visit for Uncontrolled Hypertension or Symptoms From Dissection
timeFrame: 4 weeks
measure: Hospitalization or Emergency Room Visit for Hypotension
timeFrame: 4 weeks
measure: Increase in Size or Progression of Dissection as Measured on Cardiac CT
timeFrame: 4 weeks
measure: Questionnaire Describing Patient Experience in the Study
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Venugopal Menon, M. D.
role: PRINCIPAL_INVESTIGATOR
References: