Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients

Hypertension Clinical Trial

— Dissect-BP  

Official title:

Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04116684
• Other study ID #: 19-723
• Status: Terminated
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: January 20, 2021

Study information

• Verified date: March 2021
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 20, 2021
• Est. primary completion date: January 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection
• Hypertension

Intervention

Device:
• Withings Digital Blood Pressure Monitor
This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	Individual incidence of death	4 weeks
Secondary	Surgical Intervention	Surgical intervention (open or endovascular)	4 weeks
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	4 weeks
Secondary	Hospitalization or Emergency Room Visit for Hypotension	Individual occurrence of hospitalization or Emergency Room visit for Hypotension	4 weeks
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	4 weeks
Secondary	Questionnaire Describing Patient Experience in the Study	Collection of answers to questionnaire describing patient experience in the study	4 weeks