Trial Outcomes & Findings for Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients (NCT NCT04116684)
NCT ID: NCT04116684
Last Updated: 2021-03-08
Results Overview
Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff.
TERMINATED
NA
4 participants
4 weeks
2021-03-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
Withings Digital Blood Pressure Monitor: This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group (Digital BP Monitoring)
n=1 Participants
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.
|
Standard of Care BP Monitoring
n=3 Participants
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
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=1 Participants
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Study terminated prematurely due to COVID-19 pandemic; no analysis was performed.
Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Individual incidence of death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Surgical intervention (open or endovascular)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Individual occurrence of hospitalization or Emergency Room visit for uncontrolled hypertension or symptoms from dissection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Individual occurrence of hospitalization or Emergency Room visit for Hypotension
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Incidence of Increase in size or progression of dissection compared to baseline as measured on cardiac CT
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 weeksPopulation: Study terminated prematurely due to COVID-19 pandemic; no analysis has been performed.
Collection of answers to questionnaire describing patient experience in the study
Outcome measures
Outcome data not reported
Adverse Events
Standard of Care BP Monitoring
Intervention Group (Digital BP Monitoring)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place