HypertensionNCT06941935
Etiological Classification-guided Individual Intervention in Primary Hypertension
A study testing Etiological Classification and Digital Intervention in people with Hypertension, run by Shanghai 10th People's Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Etiological Classification and Digital Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- Diagnosed primary hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Haonan Li, +8618829895009, 2311167@tongji.edu.cn
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200092
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Etiological Classification and Digital Intervention
- Keywords
- Etiological Classification, Digital Intervention
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Etiological Classification and Digital Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months following intervention
Secondary outcomes (4)
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.
Measured: 1/2/3 months following intervention
Change in Home Blood Pressure Monitoring
Change in home blood pressure monitoring (SBP/DBP) at 1/2months.
Measured: 1/2 months following intervention
Control Rate
Proportion of patients achieving target blood pressure at 3 months.
Measured: 3 months following intervention
Drug adjustment times
The total number of times to adjust blood pressure medication in 3 months
Measured: 3 months following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941935
- Sponsor's protocol ID
- GENESIS
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiological Classification-guided Individual Intervention in Primary Hypertension: An All-comer Registry Study
- ClinicalTrials.gov ID
- NCT06941935
- Acronym / sponsor ID
- GENESIS
- Conditions
- Hypertension
- Keywords
- Etiological Classification, Digital Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypertension precision diagnosis and treatment group | Experimental | Other: Etiological Classification and Digital Interventionparticipants will undergo etiological testing for primary hypertension, followed by tailored pharmacological treatment and digital blood pressure monitoring, with regular medication adjustments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years.
- Diagnosed primary hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
- signed informed consent.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etiological Classification and Digital InterventionEligible 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. | Other | Hypertension precision diagnosis and treatment group |
Primary outcome
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.
4 secondary outcomes
Change in 24-hour Ambulatory Blood Pressure Monitoring
Time frame: 1/2/3 months following intervention
Change in Home Blood Pressure Monitoring
Time frame: 1/2 months following intervention
Control Rate
Time frame: 3 months following intervention
Drug adjustment times
Time frame: 3 months following intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etiological Classification and Digital Intervention in people with Hypertension, run by Shanghai 10th People's Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang (18917686332, yizshcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Blood Pressure Recorded in a 1-Week Home Blood Pressure Diary (time frame: 3 months following intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.