Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients

NCT04116684 | Terminated Results FDA Device

• 1 other identifier: 19-723
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Dissection; Hypertension

Keywords

Withings Blood Pressure Monitor; Heart Rate; Ambulatory Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mortality

  4 weeks

• Surgical Intervention

  4 weeks

• Hospitalization or Emergency Room Visit for Uncontrolled Hypertension or Symptoms From Dissection

  4 weeks

• Hospitalization or Emergency Room Visit for Hypotension

  4 weeks

• Increase in Size or Progression of Dissection as Measured on Cardiac CT

  4 weeks

Study Arms (2)

Intervention Group (digital BP monitoring)

EXPERIMENTAL

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

Standard of care BP monitoring

NO INTERVENTION

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.

Interventions

Withings Digital Blood Pressure Monitor DEVICE

This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.

Intervention Group (digital BP monitoring)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who do not have a smart phone

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Aortic Dissection; Hypertension

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Results Point of Contact

• Title: Venu Menon, M. D.
• Organization: Cleveland Clinic

menonv@ccf.org

216-445-5390

Study Officials

• Venugopal Menon, M. D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: September 23, 2019
• Primary Completion: January 20, 2021
• Study Completion: January 20, 2021
• Last Updated: March 8, 2021
• Results First Posted: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)