Arterial HypertensionSOT-ART-HTNCT06722625
Telemedical Algorithm-Supported Care for Hypertension
A study testing Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process in people with Arterial Hypertension and Cardiovascular Diseases, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Hypertension is a major global health issue, affecting around 9 million people in Poland. While some studies indicate that telemonitoring benefits patients with hypertension, there is a lack of research evaluating tools that assist doctors in managing these patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arterial Hypertension, Cardiovascular Diseases
- What is being tested?
- Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Oct 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signing an informed consent to participate in the study.
- Age between 18 and 80 years.
- Diagnosis of hypertension according to the Polish Society of Hypertension criteria from 2019, either already treated or newly diagnosed.
- Blood pressure exceeding 140/90 mmHg in office measurements (during the screening visit).
Who cannot join
- Suspicion or diagnosis of secondary hypertension.
- Pregnant women, breastfeeding women, or those planning pregnancy during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences
Poznan, 60-848
Paweł Uruski, MD PhD, (+48)618546274, puruski@ump.edu.pl
About this study
Official title: Telemedical Care System for the Treatment of Arterial Hypertension Using Recommendation Algorithms to Support Diagnostic and Therapeutic Decisions
Hypertension is a major global health issue, affecting around 9 million people in Poland. While some studies indicate that telemonitoring benefits patients with hypertension, there is a lack of research evaluating tools that assist doctors in managing these patients. The objective of this study is to assess a blood pressure monitoring system with an integrated algorithm that aids doctors in the decision-making process.
Read the detailed description
The SOT-ART-HT study is a single-center, randomized, open-label trial aimed at comparing two strategies for managing arterial hypertension. Patients in the control group will receive standard care, which includes regular visits to a hypertension clinic, while those in the intervention group will receive remote care through a specialized tele-informatic system designed to assist the physician. The trial will involve 200 participants, aged 18-80, with confirmed arterial hypertension and uncontrolled office blood pressure at the screening visit. Both primary and secondary outcomes will be evaluated, with the study expected to be completed after 2026. However, early termination could occur if required by regulatory bodies, an Ethics Committee, or the Scientific Research Committee.
- Conditions
- Arterial Hypertension, Cardiovascular Diseases
- Being tested
- Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making processOther
Receiving remote care facilitated by a specialized informatic system to support the physician
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard care involving regular visits to a hypertension clinic. Patients in the control group will receive standard care. They will have appointments according to the guidelines of the Polish Society of Hypertension -initially once a month and, after achieving control (i.e., blood pressure in office measurement < 140/90 mmHg), once every 3 months. |
| Study group | Experimental | In the intervention group, a care model using a system implementing an algorithm that supports therapeutic and diagnostic decisions made by the doctor in the care of patients with AH will be applied. The algorithm identifies patients who have or have not achieved therapeutic goals and suggests actions for specific patients, but the final therapeutic and diagnostic decisions are always made by the doctor. It is emphasized that the treating physician is not bound by the algorithm's recommendations. Receives: Other: Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Achieving Arterial Blood Pressure Control
Time from study initiation to the day of achieving arterial blood pressure control, defined as a 7-day mean of home blood pressure measurements below 135/85 mmHg
Measured: After completing the presumed six-month follow-up of the last participant
Assessment of Achieving Arterial Blood Pressure control at 6 months
The time from study initiation to 6 months of participation, achieving arterial blood pressure control, defined as a 7-day average of home blood pressure measurements below 135/85 mmHg
Measured: After 6 months of participating
Secondary outcomes (4)
Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements
Analysis of Blood Pressure Values: 24-Hour Monitoring, Home Measurements, and Office Measurements
Measured: Baseline up to approximately six-months of observation
Assessment of the number of the medical visits
The number of medical visits from study initiation to completion
Measured: After completing the presumed six-month follow-up of the last participant
Assessment of the maintaining blood pressure control
Total time maintaining blood pressure control, defined as the number of days with a 7-day mean of home measurements below 135/85 mmHg
Measured: After completing the presumed six-month follow-up of the last participant
Assessment of the cost of visits
Cost of visits incurred by the medical institution and the patient
Measured: After completing the presumed six-month follow-up of the last participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722625
- Sponsor's protocol ID
- 2/XXI/2023
- Acronym
- SOT-ART-HT
- Status last verified
- Nov 2024
- First submitted
- 4 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipski D, Lewandowska K, Zurek S, Wisniewicz M, Pirog P, Tykarski A, Uruski P. Telemedical care system for the treatment of arterial hypertension using recommendation algorithms to support diagnostic and therapeutic decisions-study protocol for a single-center, randomized, controlled, open-label SOT-ART-HT trial. Trials. 2025 Sep 1;26(1):330. doi: 10.1186/s13063-025-09044-w.
PubMed 40890870
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedical Care System for the Treatment of Arterial Hypertension Using Recommendation Algorithms to Support Diagnostic and Therapeutic Decisions
- ClinicalTrials.gov ID
- NCT06722625
- Acronym / sponsor ID
- SOT-ART-HT / 2/XXI/2023
- Conditions
- Arterial Hypertension, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
Hypertension is a major global health issue, affecting around 9 million people in Poland. While some studies indicate that telemonitoring benefits patients with hypertension, there is a lack of research evaluating tools that assist doctors in managing these patients. The objective of this study is to assess a blood pressure monitoring system with an integrated algorithm that aids doctors in the decision-making process.
Detailed description
The SOT-ART-HT study is a single-center, randomized, open-label trial aimed at comparing two strategies for managing arterial hypertension. Patients in the control group will receive standard care, which includes regular visits to a hypertension clinic, while those in the intervention group will receive remote care through a specialized tele-informatic system designed to assist the physician. The trial will involve 200 participants, aged 18-80, with confirmed arterial hypertension and uncontrolled office blood pressure at the screening visit. Both primary and secondary outcomes will be evaluated, with the study expected to be completed after 2026. However, early termination could occur if required by regulatory bodies, an Ethics Committee, or the Scientific Research Committee.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard care involving regular visits to a hypertension clinic. Patients in the control group will receive standard care. They will have appointments according to the guidelines of the Polish Society of Hypertension -initially once a month and, after achieving control (i.e., blood pressure in office measurement < 140/90 mmHg), once every 3 months. |
| Study group | Experimental | Other: Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making processIn the intervention group, a care model using a system implementing an algorithm that supports therapeutic and diagnostic decisions made by the doctor in the care of patients with AH will be applied. The algorithm identifies patients who have or have not achieved therapeutic goals and suggests actions for specific patients, but the final therapeutic and diagnostic decisions are always made by the doctor. It is emphasized that the treating physician is not bound by the algorithm's recommendations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily signing an informed consent to participate in the study.
- Age between 18 and 80 years.
- Diagnosis of hypertension according to the Polish Society of Hypertension criteria from 2019, either already treated or newly diagnosed.
- Blood pressure exceeding 140/90 mmHg in office measurements (during the screening visit).
Key exclusion criteria (2 listed)
- Suspicion or diagnosis of secondary hypertension.
- Pregnant women, breastfeeding women, or those planning pregnancy during the study period.
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 |
|---|---|---|
| Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making processReceiving remote care facilitated by a specialized informatic system to support the physician | Other | Study group |
Primary outcome
Assessment of Achieving Arterial Blood Pressure Control
Time frame: After completing the presumed six-month follow-up of the last participant
Time from study initiation to the day of achieving arterial blood pressure control, defined as a 7-day mean of home blood pressure measurements below 135/85 mmHg
Assessment of Achieving Arterial Blood Pressure control at 6 months
Time frame: After 6 months of participating
The time from study initiation to 6 months of participation, achieving arterial blood pressure control, defined as a 7-day average of home blood pressure measurements below 135/85 mmHg
4 secondary outcomes
Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements
Time frame: Baseline up to approximately six-months of observation
Assessment of the number of the medical visits
Time frame: After completing the presumed six-month follow-up of the last participant
Assessment of the maintaining blood pressure control
Time frame: After completing the presumed six-month follow-up of the last participant
Assessment of the cost of visits
Time frame: After completing the presumed six-month follow-up of the last participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 40890870Lipski D, Lewandowska K, Zurek S, Wisniewicz M, Pirog P, Tykarski A, Uruski P. Telemedical care system for the treatment of arterial hypertension using recommendation algorithms to support diagnostic and therapeutic decisions-study protocol for a single-center, randomized, controlled, open-label SOT-ART-HT trial. Trials. 2025 Sep 1;26(1):330. doi: 10.1186/s13063-025-09044-w.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process in people with Arterial Hypertension and Cardiovascular Diseases, run by Poznan University of Medical Sciences at 1 site in Poland.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Dec 2024. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paweł Uruski, MD PhD ((+48) 618546274, puruski@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Achieving Arterial Blood Pressure Control (time frame: After completing the presumed six-month follow-up of the last participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06722625, which also lists 1 linked publication.
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 9 Dec 2024.