Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences
Poznan, 60-848, Poland
Location status: Recruiting
NCT Number: NCT06722625
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Poznan, 60-848, Poland
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Receiving remote care facilitated by a specialized informatic system to support the physician
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
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
Time frame: Baseline up to approximately six-months of observation
Analysis of Blood Pressure Values: 24-Hour Monitoring, Home Measurements, and Office Measurements
Time frame: After completing the presumed six-month follow-up of the last participant
The number of medical visits from study initiation to completion
Time frame: 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
Time frame: After completing the presumed six-month follow-up of the last participant
Cost of visits incurred by the medical institution and the patient
Contact information is provided by the study sponsor or research team.
Poznan University of Medical Sciences
Other
Telemedical Care System for the Treatment of Arterial Hypertension Using Recommendation Algorithms to Support Diagnostic and Therapeutic Decisions
Acronym: SOT-ART-HT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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