Arterial Hypertension, Cardiovascular Diseases
Conditions
Brief 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. 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.
Interventions
OTHEREvaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process
Receiving remote care facilitated by a specialized informatic system to support the physician
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily signing an informed consent to participate in the study. 2. Age between 18 and 80 years. 3. Diagnosis of hypertension according to the Polish Society of Hypertension criteria from 2019, either already treated or newly diagnosed. 4. Blood pressure exceeding 140/90 mmHg in office measurements (during the screening visit).
Exclusion criteria
1. Suspicion or diagnosis of secondary hypertension. 2. Pregnant women, breastfeeding women, or those planning pregnancy during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Achieving Arterial Blood Pressure Control | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements | Baseline up to approximately six-months of observation | Analysis of Blood Pressure Values: 24-Hour Monitoring, Home Measurements, and Office Measurements |
| Assessment of the number of the medical visits | After completing the presumed six-month follow-up of the last participant | The number of medical visits from study initiation to completion |
| Assessment of the maintaining blood pressure control | After completing the presumed six-month follow-up of the last participant | Total time maintaining blood pressure control, defined as the number of days with a 7-day mean of home measurements below 135/85 mmHg |
| Assessment of the cost of visits | After completing the presumed six-month follow-up of the last participant | Cost of visits incurred by the medical institution and the patient |
Countries
Poland
Contacts
Primary ContactPaweł Uruski, MD PhD
Outcome results
None listed