NCT06941935

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
56mo left

Started Jun 2025

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jun 2025Dec 2030

First Submitted

Initial submission to the registry

April 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

5.6 years

First QC Date

April 13, 2025

Last Update Submit

April 16, 2025

Conditions

Hypertension

Keywords

Etiological ClassificationDigital Intervention

Outcome Measures

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.

    3 months following intervention

Secondary Outcomes (4)

  • Change in 24-hour Ambulatory Blood Pressure Monitoring

    1/2/3 months following intervention

  • Change in Home Blood Pressure Monitoring

    1/2 months following intervention

  • Control Rate

    3 months following intervention

  • Drug adjustment times

    3 months following intervention

Study Arms (1)

Hypertension precision diagnosis and treatment group

EXPERIMENTAL

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

Interventions

Etiological Classification and Digital InterventionOTHER

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.

Hypertension precision diagnosis and treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Yi Zhang

CONTACT

18917686332yizshcn@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of Medicine

Study Record Dates

First Submitted

April 13, 2025

First Posted

April 24, 2025

Study Start

June 1, 2025

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 24, 2025

Record last verified: 2025-04

Locations

CN(2)