Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients

Not Applicable

Terminated

• Conditions: Aortic Dissection; Hypertension
• Interventions: Device: Withings Digital Blood Pressure Monitor

• Registration Number: NCT04116684
• Lead Sponsor: The Cleveland Clinic

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).

Study Timeline

• Study Start: 2019-09-23
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Primary Completion: 2021-01-20
• Study Completion: 2021-01-20
• Results First Submitted: 2021-02-10
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Results First Posted: 2021-03-08
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (digital BP monitoring)	Withings Digital Blood Pressure Monitor	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mortality	4 weeks	Individual incidence of death
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
Hospitalization or Emergency Room Visit for Hypotension	4 weeks	Individual occurrence of hospitalization or Emergency Room visit for Hypotension
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

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States