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

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.

Study Overview

• Status: Terminated
• Conditions: Hypertension; Aortic Dissection
• Intervention / Treatment: Device: Withings Digital Blood Pressure Monitor

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).

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Withings Digital Blood Pressure Monitor; This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Venugopal Menon, M. D., The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Actual): January 20, 2021
• Study Completion (Actual): January 20, 2021

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Heart Rate; Ambulatory Blood Pressure; Withings Blood Pressure Monitor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 19-723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No