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NCT Number: NCT06941935

Etiological Classification-guided Individual Intervention in Primary Hypertension

Eligible participants will first undergo a 1-week home blood pressure diary and 24-hour ambulatory blood pressure assessment. After a confirmed diagnosis of hypertension, etiological subtyping will be performed. Based on the blood pressure evaluation results and etiological classification, the most appropriate antihypertensive medication will be selected. Simultaneously, a personalized lifestyle prescription will be provided according to the patient's individual circumstances. Following medication initiation, participants will continue to monitor their blood pressure through home diaries. Monthly evaluations will be conducted, and if blood pressure fails to reach the target value, medication adjustments will be made based on the blood pressure diary until target levels are achieved. This regimen will be maintained long-term.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Shanghai Tenth People's 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

  • Age 18-65 years.
  • Diagnosed primary hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
  • signed informed consent.

Exclusion criteria

  • Secondary hypertension or arrhythmias affecting blood pressure accuracy (e.g., atrial fibrillation).
  • Comorbidities such as diabetes, chronic kidney disease (eGFR < 30 mL/min/1.73m²), coronary artery disease, heart failure, or serious valvular heart disease.
  • History of stroke or myocardial infarction.
  • Pregnancy, breastfeeding, or planning to become pregnant.
  • Life expectancy < 1 year.
  • Participation in another clinical trial.

Treatment and study plan

Etiological Classification and Digital Intervention

Other

Eligible participants will first undergo a 1-week home blood pressure diary and 24-hour ambulatory blood pressure assessment. After a confirmed diagnosis of hypertension, etiological subtyping will be performed. Based on the blood pressure evaluation results and etiological classification, the most appropriate antihypertensive medication will be selected. Simultaneously, a personalized lifestyle prescription will be provided according to the patient's individual circumstances. Following medication initiation, participants will continue to monitor their blood pressure through home diaries. Monthly evaluations will be conducted, and if blood pressure fails to reach the target value, medication adjustments will be made based on the blood pressure diary until target levels are achieved. This regimen will be maintained long-term.

Primary outcomes

  1. Changes in Blood Pressure Recorded in a 1-Week Home Blood Pressure Diary

    Time frame: 3 months following intervention

    Changes in blood pressure recorded (SBP/DBP) in a 1-week home blood pressure diary from baseline to 3 months.

Secondary outcomes

  1. Change in 24-hour Ambulatory Blood Pressure Monitoring

    Time frame: 1/2/3 months following intervention

    Change in 24-hour ambulatory blood pressure monitoring (daytime, nighttime, and overall SBP/DBP) at 1/2 /3 months.

  2. Change in Home Blood Pressure Monitoring

    Time frame: 1/2 months following intervention

    Change in home blood pressure monitoring (SBP/DBP) at 1/2months.

  3. Control Rate

    Time frame: 3 months following intervention

    Proportion of patients achieving target blood pressure at 3 months.

  4. Drug adjustment times

    Time frame: 3 months following intervention

    The total number of times to adjust blood pressure medication in 3 months

Study contacts

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

Yi Zhang

CONTACT

[email protected]

18917686332

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

Etiological Classification-guided Individual Intervention in Primary Hypertension: An All-comer Registry Study

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Apr 24, 2025
Registry last updated
Apr 24, 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.

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