Etiological Classification-guided Individual Intervention in Primary Hypertension

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Etiological Classification and Digital Intervention

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi Zhang; Phone Number: 18917686332; Email: yizshcn@gmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200072
      • Department of Cardiology, Shanghai Tenth People's Hospital
      • Contact: Haonan Li; Phone Number: +8618829895009; Email: 2311167@tongji.edu.cn
    • Shanghai, Shanghai, China, 200092
      • Shanghai Tenth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months following intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1/2/3 months following intervention
Change in Home Blood Pressure Monitoring	Change in home blood pressure monitoring (SBP/DBP) at 1/2months.	1/2 months following intervention
Control Rate	Proportion of patients achieving target blood pressure at 3 months.	3 months following intervention
Drug adjustment times	The total number of times to adjust blood pressure medication in 3 months	3 months following intervention

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 13, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Digital Intervention; Etiological Classification
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Essential Hypertension; Hypertension
• Other Study ID Numbers: GENESIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No