MedDataX Logo

Telemedical Algorithm-Supported Care for Hypertension

NCT ID: NCT06722625

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Arterial Hypertension Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Study group

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.

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluation 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Poznan, , Poland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Poland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paweł Uruski, MD PhD

Role: CONTACT

Phone: (+48) 618546274

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Paweł Uruski, MD PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40890870 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2/XXI/2023

Identifier Type: -

Identifier Source: org_study_id