HypertensionNCT07124728
Syntrillo Telehealth Stroke Risk Reduction Study
A study testing Technology-enabled Telehealth Care Plan, Blood Pressure Monitoring Device and Tenovi Smart Pillbox in people with Hypertension and Hypertension (HTN), run by Syntrillo, Inc at 1 site in United States.
Trial summary
A prospective, single-arm, open-label study evaluating the impact of Syntrillo's telehealth program on stroke risk factors, particularly blood pressure, among 68 high-risk patients. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hypertension, Hypertension (HTN), Stroke Prevention
- What is being tested?
- Technology-enabled Telehealth Care Plan, Blood Pressure Monitoring Device and Tenovi Smart Pillbox
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 22 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 30
- Diagnosis of hypertension
- One or more of the following:
- Dtrial fibrillation
- Diabetes
- Chronic kidney disease (stage 2+)
Show all 12Show fewer
- Obesity (class 2+)
- Obstructive sleep apnea
- Coronary artery disease
- Hyperlipidemia
- Carotid stenosis (greater than or equal to 50%)
- Congestive heart failure
Who cannot join
- History of stroke or TIA
- Inability to consent or understand study
- Residence in long-term acute care facility
- Inability to ambulate independently
- Non-English speaking
- No internet access
- Not residing in Virginia
- Pregnancy or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Syntrillo's Telehealth Service on Stroke Risk Factor Reduction in At-risk Patients
A prospective, single-arm, open-label study evaluating the impact of Syntrillo's telehealth program on stroke risk factors, particularly blood pressure, among 68 high-risk patients. The 6-month intervention includes personalized remote care with blood pressure monitoring, wearable tracking, and multidisciplinary telehealth visits.
Read the detailed description
Participants ≥30 years old with hypertension and at least one of the following conditions: atrial fibrillation, diabetes, chronic kidney disease (stage 2 or higher), obesity (class 2 or higher), obstructive sleep apnea, coronary artery disease, hyperlipidemia, carotid stenosis (of 50% or greater), and/or congestive heart failure will be enrolled in a 6-month telehealth intervention focused on stroke risk reduction. The program includes use of home blood pressure monitors, smart pillboxes, wearable activity trackers, and a multidisciplinary team for personalized care. Primary endpoint is change in systolic blood pressure. Additional endpoints include diastolic BP, inflammatory markers (hs-CRP), and cardiovascular biomarkers (resting heart rate, HRV). The study is single-arm, non-randomized, and exploratory in design.
- Being tested
- Technology-enabled Telehealth Care Plan, Blood Pressure Monitoring Device, Tenovi Smart Pillbox, Wearable Activity Trackers (Fitbit or Apple Watch), Healthie EHR
- Keywords
- stroke prevention, telehealth, telemedicine, blood pressure, remote patient monitoring, digital health, heart rate variability, inflammation, hypertension
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology-enabled Telehealth Care PlanBehavioural
Participants receive a 6 month personalized telehealth intervention via a multidisciplinary care team, delivering care via a secure digital platform, including education, risk assessment, lifestyle coaching, medical history review, and stroke risk reduction planning. The Healthie EHR is used for communication, documentation, and data integration. Syntrillo Navigators and neurology providers conduct onboarding, telemedicine visits, and coordination with patient's primary care providers and care team.
Blood Pressure Monitoring DeviceDevice
Participants will receive a cellular-enabled, FDA-cleared blood pressure monitor supplied by Tenovi. Blood pressure is measured twice daily during baseline and at least once daily throughout the 6-month intervention. Data is transmitted via a secure gateway to the Healthie EHR for real-time monitoring and analysis.
Tenovi Smart PillboxDevice
Participants receive a connected 7-day smart pillbox that detects compartment openings and refills. Medication adherence data is uploaded in real time to a secure dashboard and integrated into the EHR.
Wearable Activity Trackers (Fitbit or Apple Watch)Device
Participants will utilize a commercially available wearable activity tracker to monitor step counts, resting heart rate, and heart rate variability. This data is integrated into the EHR. Devices will be provided if participants do not already own one.
Healthie EHROther
HIPAA-compliant electronic medical record system used for participant management, secure communication, clinical documentation, and device data integration, consisting of custom workflows used for risk tracking and care planning.
Secure Messaging Platforms (TigerConnect, Weave, AirCall)Other
Participants and providers may communicate using secure messaging platforms for appointment reminders, assessments, and care support, to enhance participation engagement and care coordination.
Antihypertensive Medication ManagementDrug
Participants may be prescribed or have existing antihypertensive regimens adjusted (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, etc) by neurologists or nurse practitioners based on individual risk assessments and clinical findings during the study. Changed will be recorded in EHR.
Statin Medication ManagementDrug
Lipid-lowering medications, including statins, may be initiated or adjusted as part of participants' care plans. Medication use is guided by cardiovascular risk and AHA guidelines. Changed will be recorded in EHR.
Antiplatelet or Anticoagulant TherapyDrug
Participants with atrial fibrillation or elevated cardiovascular risk may be started on or have changes to antiplatelet or anticoagulant therapy. Medication decisions are made by neurologist or nurse practitioners during telemedicine visits. Changed will be recorded in EHR.
Laboratory Blood Test CollectionProcedure or surgery
Blood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine Stroke Prevention Program | Experimental | Participants will receive a 6-month personalized telehealth intervention including remote patient monitoring, blood pressure management, lifestyle counseling, wearable monitoring, and multidisciplinary telemedicine visits via the Healthie platform. Receives: Behavioral: Technology-enabled Telehealth Care Plan; Device: Blood Pressure Monitoring Device; Device: Tenovi Smart Pillbox; Device: Wearable Activity Trackers (Fitbit or Apple Watch); Other: Healthie EHR; Other: Secure Messaging Platforms (TigerConnect, Weave, AirCall); Drug: Antihypertensive Medication Management; Drug: Statin Medication Management; Drug: Antiplatelet or Anticoagulant Therapy; Procedure: Laboratory Blood Test Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure
This measure evaluates the average change in systolic blood pressure (SBP), which is the pressure in the arteries when the heart beats. Blood pressure is measured by participants at home using a Tenovi FDA-cleared digital blood pressure monitor. Baseline SBP is calculated using the first 10 valid readings taken during the initial week of monitoring. The 6-month value is calculated from the last 10 valid readings taken in the final week of the intervention. The study aims to observe a reduction of at least 10 mmHg in average SBP over the intervention period.
Measured: Baseline to 6 months
Secondary outcomes (6)
Change in Diastolic Blood Pressure
This measure evaluates the average change in systolic blood pressure (SBP), which is the pressure in the arteries when the heart beats. Blood pressure is measured by participants at home using a Tenovi FDA-cleared digital blood pressure monitor. Baseline SBP is calculated using the first 10 valid readings taken during the initial week of monitoring. The 6-month value is calculated from the last 10 valid readings taken in the final week of the intervention. The study aims to observe a reduction of at least 10 mmHg in average SBP over the intervention period.
Measured: Baseline to 6 months
Change in Systolic Blood Pressure Variability
This measure assesses the variability of systolic blood pressure (SBP) as measured by the standard deviation (SD) of SBP readings. Variability is calculated from 20 readings collected at baseline (first 2 weeks) and another 20 readings at the end of the intervention (final 2 weeks). Measurements are taken using the Tenovi home blood pressure monitor. The target is a 10% reduction in the standard deviation of SBP values, indicating more stable blood pressure control.
Measured: Baseline to 6 months
Change in Pulse Pressure
This measure evaluates the change in pulse pressure (PP), defined as the difference between systolic and diastolic blood pressure. PP is a marker of arterial stiffness and cardiovascular risk. It is calculated from 20 home blood pressure readings collected at the start and again at the end of the 6-month intervention. Measurements are obtained using the Tenovi device. The study target is a reduction of at least 5 mmHg in average pulse pressure.
Measured: Baseline to 6 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
This measure examines changes in high-sensitivity C-reactive protein (hs-CRP), a blood marker of systemic inflammation and cardiovascular risk. hs-CRP levels are measured from blood samples collected at baseline and again at the 6-month time point. The study aims to observe a mean reduction of at least 20% in hs-CRP concentration over the course of the intervention.
Measured: Baseline to 6 months
Change in Resting Heart Rate
This measure evaluates the change in resting heart rate (RHR), defined as the number of heartbeats per minute when the body is at rest. RHR is measured using participant-worn Fitbit or Apple Watch devices. The average RHR is calculated from 20 data points collected during the initial monitoring period and compared with 20 data points collected in the final weeks of the intervention. The study aims to observe a mean decrease of at least 5 beats per minute in resting heart rate.
Measured: Baseline to 6 months
Change in Heart Rate Variability
This measure tracks changes in heart rate variability (HRV), a measure of autonomic nervous system function. HRV is assessed using the standard deviation of NN intervals (SDNN), collected from data provided by Fitbit or Apple Watch wearable devices. Baseline SDNN is calculated from 40 measurements during the first 2 weeks, and compared to 40 measurements taken during the final 2 weeks of the study. The target is a 10% or greater increase in average SDNN over the study period.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start30 Jul 2025
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syntrillo, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124728
- Sponsor's protocol ID
- 2025003
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data may be used internally for algorithm development and clinical workflow optimization, but will not be publicly shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Syntrillo's Telehealth Service on Stroke Risk Factor Reduction in At-risk Patients
- ClinicalTrials.gov ID
- NCT07124728
- Acronym / sponsor ID
- 2025003
- Keywords
- stroke prevention, telehealth, telemedicine, blood pressure, remote patient monitoring, digital health, heart rate variability, inflammation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Syntrillo, IncUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm, open-label study evaluating the impact of Syntrillo's telehealth program on stroke risk factors, particularly blood pressure, among 68 high-risk patients. The 6-month intervention includes personalized remote care with blood pressure monitoring, wearable tracking, and multidisciplinary telehealth visits.
Detailed description
Participants ≥30 years old with hypertension and at least one of the following conditions: atrial fibrillation, diabetes, chronic kidney disease (stage 2 or higher), obesity (class 2 or higher), obstructive sleep apnea, coronary artery disease, hyperlipidemia, carotid stenosis (of 50% or greater), and/or congestive heart failure will be enrolled in a 6-month telehealth intervention focused on stroke risk reduction. The program includes use of home blood pressure monitors, smart pillboxes, wearable activity trackers, and a multidisciplinary team for personalized care. Primary endpoint is change in systolic blood pressure. Additional endpoints include diastolic BP, inflammatory markers (hs-CRP), and cardiovascular biomarkers (resting heart rate, HRV). The study is single-arm, non-randomized, and exploratory in design.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine Stroke Prevention Program | Experimental | Behavioral: Technology-enabled Telehealth Care Plan, Device: Blood Pressure Monitoring Device, Device: Tenovi Smart Pillbox, Device: Wearable Activity Trackers (Fitbit or Apple Watch), Other: Healthie EHR, Other: Secure Messaging Platforms (TigerConnect, Weave, AirCall), Drug: Antihypertensive Medication Management, Drug: Statin Medication Management, Drug: Antiplatelet or Anticoagulant Therapy, Procedure: Laboratory Blood Test CollectionParticipants will receive a 6-month personalized telehealth intervention including remote patient monitoring, blood pressure management, lifestyle counseling, wearable monitoring, and multidisciplinary telemedicine visits via the Healthie platform. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age greater than or equal to 30
- Diagnosis of hypertension
- One or more of the following:
- Dtrial fibrillation
- Diabetes
Key exclusion criteria (8 listed)
- History of stroke or TIA
- Inability to consent or understand study
- Residence in long-term acute care facility
- Inability to ambulate independently
- Non-English speaking
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 |
|---|---|---|
| Technology-enabled Telehealth Care PlanParticipants receive a 6 month personalized telehealth intervention via a multidisciplinary care team, delivering care via a secure digital platform, including education, risk assessment, lifestyle coaching, medical history review, and stroke risk reduction planning. The Healthie EHR is used for communication, documentation, and data integration. Syntrillo Navigators and neurology providers conduct onboarding, telemedicine visits, and coordination with patient's primary care providers and care team. | Behavioural | Telemedicine Stroke Prevention Program |
| Blood Pressure Monitoring DeviceParticipants will receive a cellular-enabled, FDA-cleared blood pressure monitor supplied by Tenovi. Blood pressure is measured twice daily during baseline and at least once daily throughout the 6-month intervention. Data is transmitted via a secure gateway to the Healthie EHR for real-time monitoring and analysis. | Device | Telemedicine Stroke Prevention Program |
| Tenovi Smart PillboxParticipants receive a connected 7-day smart pillbox that detects compartment openings and refills. Medication adherence data is uploaded in real time to a secure dashboard and integrated into the EHR. | Device | Telemedicine Stroke Prevention Program |
| Wearable Activity Trackers (Fitbit or Apple Watch)Participants will utilize a commercially available wearable activity tracker to monitor step counts, resting heart rate, and heart rate variability. This data is integrated into the EHR. Devices will be provided if participants do not already own one. | Device | Telemedicine Stroke Prevention Program |
| Healthie EHRHIPAA-compliant electronic medical record system used for participant management, secure communication, clinical documentation, and device data integration, consisting of custom workflows used for risk tracking and care planning. | Other | Telemedicine Stroke Prevention Program |
| Secure Messaging Platforms (TigerConnect, Weave, AirCall)Participants and providers may communicate using secure messaging platforms for appointment reminders, assessments, and care support, to enhance participation engagement and care coordination. | Other | Telemedicine Stroke Prevention Program |
| Antihypertensive Medication ManagementParticipants may be prescribed or have existing antihypertensive regimens adjusted (ACE inhibitors, beta blockers, calcium channel blockers, diuretics, etc) by neurologists or nurse practitioners based on individual risk assessments and clinical findings during the study. Changed will be recorded in EHR. | Drug | Telemedicine Stroke Prevention Program |
| Statin Medication ManagementLipid-lowering medications, including statins, may be initiated or adjusted as part of participants' care plans. Medication use is guided by cardiovascular risk and AHA guidelines. Changed will be recorded in EHR. | Drug | Telemedicine Stroke Prevention Program |
| Antiplatelet or Anticoagulant TherapyParticipants with atrial fibrillation or elevated cardiovascular risk may be started on or have changes to antiplatelet or anticoagulant therapy. Medication decisions are made by neurologist or nurse practitioners during telemedicine visits. Changed will be recorded in EHR. | Drug | Telemedicine Stroke Prevention Program |
| Laboratory Blood Test CollectionBlood samples may be collected at baseline and at 6 months to assess inflammation through high-sensitivity C-reactive protein. | Procedure or surgery | Telemedicine Stroke Prevention Program |
Primary outcome
Change in Systolic Blood Pressure
Time frame: Baseline to 6 months
This measure evaluates the average change in systolic blood pressure (SBP), which is the pressure in the arteries when the heart beats. Blood pressure is measured by participants at home using a Tenovi FDA-cleared digital blood pressure monitor. Baseline SBP is calculated using the first 10 valid readings taken during the initial week of monitoring. The 6-month value is calculated from the last 10 valid readings taken in the final week of the intervention. The study aims to observe a reduction of at least 10 mmHg in average SBP over the intervention period.
6 secondary outcomes
Change in Diastolic Blood Pressure
Time frame: Baseline to 6 months
Change in Systolic Blood Pressure Variability
Time frame: Baseline to 6 months
Change in Pulse Pressure
Time frame: Baseline to 6 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Baseline to 6 months
Change in Resting Heart Rate
Time frame: Baseline to 6 months
Change in Heart Rate Variability
Time frame: Baseline to 6 months
Results and safety
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No. De-identified data may be used internally for algorithm development and clinical workflow optimization, but will not be publicly shared.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology-enabled Telehealth Care Plan, Blood Pressure Monitoring Device and Tenovi Smart Pillbox in people with Hypertension and Hypertension (HTN), run by Syntrillo, Inc 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 12 inclusion and 8 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 30 Jul 2026. 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?
The study was stopped early (reason given: Insufficient enrollment). Results are not available in the source record.
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?
Change in Systolic Blood Pressure (time frame: Baseline to 6 months). 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 30 Jul 2026.