Aortic DissectionDissect-BPNCT04116684
Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients
A study testing Withings Digital Blood Pressure Monitor in people with Aortic Dissection and Hypertension, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Dissection, Hypertension
- What is being tested?
- Withings Digital Blood Pressure Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2019to 20 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients who do not have a smart phone
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Aortic Dissection, Hypertension
- Being tested
- Withings Digital Blood Pressure Monitor
- Keywords
- Withings Blood Pressure Monitor, Heart Rate, Ambulatory Blood Pressure
- Medical subject headings
- Aortic Dissection, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withings Digital Blood Pressure MonitorDevice
This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure at End of 4 Weeks
Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff.
Measured: 4 weeks
Secondary outcomes (6)
Mortality
Individual incidence of death
Measured: 4 weeks
Surgical Intervention
Surgical intervention (open or endovascular)
Measured: 4 weeks
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
Measured: 4 weeks
Hospitalization or Emergency Room Visit for Hypotension
Individual occurrence of hospitalization or Emergency Room visit for Hypotension
Measured: 4 weeks
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
Measured: 4 weeks
Questionnaire Describing Patient Experience in the Study
Collection of answers to questionnaire describing patient experience in the study
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start23 Sep 2019
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Why it stopped: Difficulty with patient enrollment and carrying out the study logistics due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venugopal Menon, M. D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116684
- Sponsor's protocol ID
- 19-723
- Acronym
- Dissect-BP
- Status last verified
- Mar 2021
- First submitted
- 3 Oct 2019
- Last updated
- 8 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Home Blood Pressure Monitoring in Type B Aortic Dissection Patients
- ClinicalTrials.gov ID
- NCT04116684
- Acronym / sponsor ID
- Dissect-BP / 19-723
- Conditions
- Aortic Dissection, Hypertension
- Keywords
- Withings Blood Pressure Monitor, Heart Rate, Ambulatory Blood Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with patient enrollment and carrying out the study logistics due to COVID-19
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 7 Oct 2019 (actual)
- Results
- Posted 8 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (digital BP monitoring) | Experimental | Device: Withings Digital Blood Pressure MonitorThis group will receive a Withings digital BP monitor to transmit recordings to the study team who will make medication adjustments. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who do not have a smart phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withings Digital Blood Pressure MonitorThis is a home digital blood pressure monitor that can transmit recordings via a user's smartphone. | Device | Intervention Group (digital BP monitoring) |
Primary outcome
Systolic Blood Pressure at End of 4 Weeks
Time frame: 4 weeks
Systolic Blood Pressure at end of 4 weeks as measured by 24 hour ambulatory cuff.
6 secondary outcomes
Mortality
Time frame: 4 weeks
Surgical Intervention
Time frame: 4 weeks
Hospitalization or Emergency Room Visit for Uncontrolled Hypertension or Symptoms From Dissection
Time frame: 4 weeks
Hospitalization or Emergency Room Visit for Hypotension
Time frame: 4 weeks
Increase in Size or Progression of Dissection as Measured on Cardiac CT
Time frame: 4 weeks
Questionnaire Describing Patient Experience in the Study
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venugopal Menon, M. D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withings Digital Blood Pressure Monitor in people with Aortic Dissection and Hypertension, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure at End of 4 Weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.