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

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04116684
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Dissection; Hypertension	Device: Withings Digital Blood Pressure Monitor	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients
• Actual Study Start Date: Sep 23, 2019
• Actual Primary Completion Date: Jan 20, 2021
• Actual Study Completion Date: Jan 20, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Mortality [4 weeks]

   Individual incidence of death

2. Surgical Intervention [4 weeks]

   Surgical intervention (open or endovascular)

3. 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

4. Hospitalization or Emergency Room Visit for Hypotension [4 weeks]

   Individual occurrence of hospitalization or Emergency Room visit for Hypotension

5. 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

6. Questionnaire Describing Patient Experience in the Study [4 weeks]

   Collection of answers to questionnaire describing patient experience in the study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 1, 2019

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT04116684
• Other Study ID Numbers: 19-723
• First Posted: Oct 7, 2019
• Last Update Posted: Mar 8, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by The Cleveland Clinic: Withings Blood Pressure Monitor; Heart Rate; Ambulatory Blood Pressure
• Additional relevant MeSH terms: Aneurysm, Dissecting

Study Results

Participant Flow

Arm/Group Title	Standard of Care BP Monitoring	Intervention Group (Digital BP Monitoring)
Arm/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.	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Period Title: Overall Study
STARTED	3	1
COMPLETED	1	1
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Intervention Group (Digital BP Monitoring)	Standard of Care BP Monitoring	Total
Arm/Group Description	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.	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.	Total of all reporting groups
Overall Participants	1	3	4
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	1 100%	3 100%	4 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%	2 66.7%	3 75%
Male	0 0%	1 33.3%	1 25%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Systolic Blood Pressure at End of 4 Weeks
Description	Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff.
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Study terminated prematurely due to COVID-19 pandemic; no analysis was performed.

Arm/Group Title	Standard of Care BP Monitoring	Intervention Group (Digital BP Monitoring)
Arm/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.	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Measure Participants	0	0

2. Secondary Outcome

Title	Mortality
Description	Individual incidence of death
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.

Arm/Group Title	Standard of Care BP Monitoring	Intervention Group (Digital BP Monitoring)
Arm/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.	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Measure Participants	0	0

3. Secondary Outcome

Title	Surgical Intervention
Description	Surgical intervention (open or endovascular)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.

Arm/Group Title	Standard of Care BP Monitoring	Intervention Group (Digital BP Monitoring)
Arm/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.	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Measure Participants	0	0

4. Secondary Outcome

Title	Hospitalization or Emergency Room Visit for Uncontrolled Hypertension or Symptoms From Dissection
Description	Individual occurrence of hospitalization or Emergency Room visit for uncontrolled hypertension or symptoms from dissection
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.

Arm/Group Title	Standard of Care BP Monitoring	Intervention Group (Digital BP Monitoring)
Arm/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.	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Measure Participants	0	0

5. Secondary Outcome

Title	Hospitalization or Emergency Room Visit for Hypotension
Description	Individual occurrence of hospitalization or Emergency Room visit for Hypotension
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.

Arm/Group Title	Standard of Care BP Monitoring	Intervention Group (Digital BP Monitoring)
Arm/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.	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Measure Participants	0	0

6. Secondary Outcome

Title	Increase in Size or Progression of Dissection as Measured on Cardiac CT
Description	Incidence of Increase in size or progression of dissection compared to baseline as measured on cardiac CT
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.

Arm/Group Title	Standard of Care BP Monitoring	Intervention Group (Digital BP Monitoring)
Arm/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.	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Measure Participants	0	0

7. Secondary Outcome

Title	Questionnaire Describing Patient Experience in the Study
Description	Collection of answers to questionnaire describing patient experience in the study
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.

Arm/Group Title	Standard of Care BP Monitoring	Intervention Group (Digital BP Monitoring)
Arm/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.	This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
Measure Participants	0	0

Adverse Events

Time Frame	2 weeks and 4 weeks
Arm/Group Title	Standard of Care BP Monitoring		Intervention Group (Digital BP Monitoring)
Arm/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.		This group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
All Cause Mortality
	Standard of Care BP Monitoring		Intervention Group (Digital BP Monitoring)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)
Serious Adverse Events
	Standard of Care BP Monitoring		Intervention Group (Digital BP Monitoring)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care BP Monitoring		Intervention Group (Digital BP Monitoring)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.