Etiological Classification-guided Individual Intervention in Primary Hypertension

NCT ID: NCT06941935

Last Updated: 2025-04-24

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

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypertension precision diagnosis and treatment group

participants will undergo etiological testing for primary hypertension, followed by tailored pharmacological treatment and digital blood pressure monitoring, with regular medication adjustments.

Group Type EXPERIMENTAL

Etiological Classification and Digital Intervention

Intervention Type 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.

Interventions

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Etiological Classification and Digital 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai 10th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ya-Wei Xu

professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Yi Zhang

Role: CONTACT

18917686332

Facility Contacts

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Haonan Li

Role: primary

+8618829895009

Other Identifiers

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GENESIS

Identifier Type: -

Identifier Source: org_study_id

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