Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients (Dissect-BP)

NeuroTherapia, Inc.

Status: Terminated

Conditions: Hypertension; Aortic Dissection

Treatments: Device: Withings Digital Blood Pressure Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04116684

19-723

Details and patient eligibility

About

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.

Full 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).

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Intervention Group (digital BP monitoring)

Experimental group

Description:

This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments.

Treatment:

Device: Withings Digital Blood Pressure Monitor

Standard of care BP monitoring

No Intervention group

Description:

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.