Telemedical Algorithm-Supported Care for Hypertension

Not Applicable

Recruiting

• Conditions: Arterial Hypertension; Cardiovascular Diseases

• Registration Number: NCT06722625
• Lead Sponsor: Poznan University of Medical Sciences

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.

Study Timeline

• Study Start: 2023-10-01
• Status Verified: 2024-11
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Hypertensiology, Angiology and Internal Medicine, Poznan University of Medical Sciences; 🇵🇱 Poznań, Poland