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NCT Number: NCT06722625

Telemedical Algorithm-Supported Care for Hypertension

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences

Poznan, 60-848, Poland

Location status: Recruiting

Location contact

Paweł Uruski, MD PhD

CONTACT

[email protected]

(+48)618546274

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Suspicion or diagnosis of secondary hypertension.
  • Pregnant women, breastfeeding women, or those planning pregnancy during the study period.

Treatment and study plan

Evaluation of a blood pressure monitoring system with an integrated algorithm that supports the doctor's decision-making process

Other

Receiving remote care facilitated by a specialized informatic system to support the physician

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Assessment of blood pressure values in 24-hour monitoring, home measurements, and office measurements

    Time frame: Baseline up to approximately six-months of observation

    Analysis of Blood Pressure Values: 24-Hour Monitoring, Home Measurements, and Office Measurements

  2. Assessment of the number of the medical visits

    Time frame: After completing the presumed six-month follow-up of the last participant

    The number of medical visits from study initiation to completion

  3. Assessment of the maintaining blood pressure control

    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

  4. Assessment of the cost of visits

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Paweł Uruski, MD PhD

CONTACT

[email protected]

(+48) 618546274

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Telemedical Care System for the Treatment of Arterial Hypertension Using Recommendation Algorithms to Support Diagnostic and Therapeutic Decisions

Acronym: SOT-ART-HT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

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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