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OpenTrials
Completed

NCT Number: NCT05526300

Intelligent Hypertension Intervention Study

To explore whether the application of intelligent hypertension management system can effectively reduce blood pressure in hypertensive patients. A total of 320 eligible subjects will be recruited and randomization to two groups. The standard care group (n=160) will receive conventional hypertension treatment with baseline data collected.Wearable blood pressure monitoring device management group (intervention group, n=160) will receive blood pressure monitoring remotely everyday and antihypertension medication treatment. Primary outcome is Net change in systolic blood pressure from baseline to 3 months follow-up. Secondary outcomes include Net change in diastolic blood pressure hypertension control ratio (BP < 140/90 mmHg)

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Key information

Conditions

To Explore Whether the Application of Intelligent Hypertension Management System Can Effectively Reduce Blood Pressure in Hypertensive Patients

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai tongren hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged more than 18 years old, less than or equal to 75 years old.
  • Hypertensive patients (systolic/diastolic blood pressure ≥140/90 mmHg at two separate screening/baseline visits)
  • Patients or guardians can skillfully use devices such as smartphones and electronic sphygmomanometers
  • Voluntarily joined and signed the informed consent

Exclusion criteria

  • Pregnant women or women planning to become pregnant within the next year;
  • Patients with secondary hypertension
  • Patients with life expectancy less than 1 year
  • Severe hepatic and renal insufficiency (ALT > 5 times ULA, eGFR < 15ml/min/1.73mm2)
  • Known active malignancy disease
  • The researcher believes that patients who are not suitable to participate in this study

Treatment and study plan

Intelligent Hypertension Management System

Device

The intelligent hypertension management system is used to remotely detect the blood pressure of hypertensive patients

The standard care

Other

The standard care

Primary outcomes

  1. Net change in systolic blood pressure from baseline to 3 months follow-up

    Time frame: one and three months after study

Secondary outcomes

  1. Net change in diastolic blood pressure

    Time frame: one and three months after study

  2. Hypertension control ratio (BP < 140/90 mmHg)

    Time frame: one and three months after study

Sponsors and collaborators

Lead sponsor

Shanghai Tong Ren Hospital

Other

Registry information

Official study title

Randomized Study of Antihypertensive Intervention by Intelligent Hypertension Management System

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 2, 2022
Registry last updated
May 21, 2025

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.