Etiological Classification-guided Individual Intervention in Primary Hypertension

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai 10th People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years.

Diagnosed primary hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).

signed informed consent.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Etiological Classification and Digital Intervention

    Other intervention

    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.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Hypertension precision diagnosis and treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
3 months following intervention

Secondary outcomes

1

Change in 24-hour Ambulatory Blood Pressure Monitoring

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

Time frame
1/2/3 months following intervention
2

Change in Home Blood Pressure Monitoring

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

Time frame
1/2 months following intervention
3

Control Rate

Proportion of patients achieving target blood pressure at 3 months.

Time frame
3 months following intervention
4

Drug adjustment times

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

Time frame
3 months following intervention

Other outcomes

Sponsors and contacts

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