HypertensionPhase 4HEMOPHENONCT07240909
Antihypertensive Drug Selection Based on Hemodynamic Phenotypes
A Phase 4 study testing hemodynamics-based individualized antihypertensive therapy and guideline-based conventional treatment in people with Hypertension, run by The Third Xiangya Hospital of Central South University.
Trial summary
The goal of this clinical trial is to explore the clinical efficacy and safety of individualized antihypertensive medication guided by hemodynamic phenotyping. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- hemodynamics-based individualized antihypertensive therapy and guideline-based conventional treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2026
- Phase
- Phase 4
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥30 and <80 years, regardless of gender;
- Confirmed diagnosis of hypertension meeting the criteria outlined in the 2024 Chinese Hypertension Guidelines: office blood pressure ≥140/90 mmHg and home blood pressure ≥135/85 mmHg;
- Mild to moderate hypertension, with office blood pressure ranging from 140-179/90-109 mmHg;
- No prior use of antihypertensive medications;
- Voluntary participation in the study with written informed consent obtained.
Who cannot join
- Diagnosed or highly suspected secondary hypertension;
- Classified as mixed type according to hemodynamic typing;
- Allergy to the intended antihypertensive medications;
- Dysphagia;
- Pregnant or lactating women;
- Potential pregnancy plans during the trial period;
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- Uncorrected electrolyte disturbances;
- Severe organ dysfunction;
- Comorbid conditions leading to inaccurate blood pressure measurement;
- Comorbid conditions or states unsuitable for noninvasive hemodynamic measurement via bioelectrical impedance;
- Comorbid conditions contraindicating or requiring caution with trial medications;
- Comorbid conditions affecting the absorption, distribution, metabolism, or excretion of trial drugs;
- Concurrent or planned use of medications contraindicated or requiring caution with trial drugs;
- Concurrent or planned use of medications interfering with trial outcomes;
- Clinician's assessment deems the patient unsuitable for the trial's antihypertensive regimen;
- Current participation in other clinical studies that may interfere with the conduct of this trial.
About this study
Official title: A Multicenter, Randomized, PROBE Trial on Antihypertensive Drug Selection Based on Hemodynamic Phenotypes Defined by Bioelectrical Impedance Analysis
The goal of this clinical trial is to explore the clinical efficacy and safety of individualized antihypertensive medication guided by hemodynamic phenotyping. The main questions it aims to answer are:
- Does hemodynamics-based individualized antihypertensive therapy achieve better blood pressure control compared to guideline-based conventional therapy?
- Does hemodynamics-based individualized therapy have comparable safety to guideline-based conventional treatment? Researchers will compare hemodynamics-based individualized antihypertensive therapy to guideline-based conventional treatment to see if the former is better than the latter.
Read more
Participants will:
- Take hemodynamics-based individualized antihypertensive therapy or guideline-based conventional treatment every day for 8 weeks
- Visit the clinic once every 4 weeks for checkups and tests
- Keep a diary of their symptoms and any treatment
- Conditions
- Hypertension
- Being tested
- hemodynamics-based individualized antihypertensive therapy, guideline-based conventional treatment
- Keywords
- hypertension, anti-hypertensive therapy, Hemodynamics
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodynamics-based individualized antihypertensive therapyDrug
Also called individualized therapy
The antihypertensive strategy is individualized according to the patient's hemodynamic indices:
High-resistance type: Amlodipine Besylate Tablets 5mg, once daily, orally. High cardiac output type: Metoprolol Sustained-Release Tablets 47.5mg, once daily, orally.
Hypervolemic type: Indapamide Tablets 2.5mg, once daily, orally. Participants will take the therapy for 8 weeks.
guideline-based conventional treatmentDrug
Also called conventional treatment
Developing a monotherapy antihypertensive treatment plan for participants based on the 2024 Chinese hypertension guidelines.
Participants will take this treatment for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| hemodynamics-based individualized antihypertensive therapy | Experimental | The antihypertensive strategy is individualized according to the patient's hemodynamic indices:
High-resistance type: Amlodipine Besylate Tablets 5mg, once daily, orally. High cardiac output type: Metoprolol Sustained-Release Tablets 47.5mg, once daily, orally.
Hypervolemic type: Indapamide Tablets 2.5mg, once daily, orally. Receives: Drug: hemodynamics-based individualized antihypertensive therapy |
| guideline-based conventional therapy | Active comparator | Developing a monotherapy antihypertensive treatment plan for participants based on the 2024 Chinese hypertension guidelines Receives: Drug: guideline-based conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in office systolic blood pressure reduction
Difference in office systolic blood pressure reduction between two groups.
Measured: 8 weeks after treatment
Secondary outcomes (15)
Reduction difference in office systolic blood pressure
Reduction difference in office systolic blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 4 weeks after treatment
Reduction difference in office diastolic blood pressure
Reduction difference in office diastolic blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 4 weeks after treatment
Reduction difference in office mean blood pressure
Reduction difference in office mean blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 4 weeks after treatment
Difference in pulse rate changes
Difference in pulse rate changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 4 weeks after treatment
Difference in blood pressure target rate
Difference in blood pressure target rate (both systolic and diastolic blood pressure will be measured) between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 4 weeks after treatment
Difference of systemic vascular resistance index (SVRI) changes
Difference of systemic vascular resistance index (SVRI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 4 weeks after treatment
Difference of cardiac index (CI) changes
Difference of cardiac index (CI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 4 weeks after treatment
Difference of thoracic fluid content (TFC) changes
Difference of thoracic fluid content (TFC) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 4 weeks after treatment
Reduction difference in office diastolic blood pressure
Reduction difference in office diastolic blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 8 weeks after treatment
Reduction difference in office mean blood pressure
Reduction difference in office mean blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 8 weeks after treatment
Difference in pulse rate changes
Difference in pulse rate changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy
Measured: 8 weeks after treatment
Difference in blood pressure target rate
Difference in blood pressure target rate (both systolic and diastolic blood pressure will be measured) between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy
Measured: 8 weeks after treatment
Difference of systemic vascular resistance index (SVRI) changes
Difference of systemic vascular resistance index (SVRI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 8 weeks after treatment
Difference of cardiac index (CI) changes
Difference of cardiac index (CI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 8 weeks after treatment
Difference of thoracic fluid content (TFC) changes
Difference of thoracic fluid content (TFC) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study startJan 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240909
- Sponsor's protocol ID
- R25070
- Acronym
- HEMOPHENO
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded data (without personal identification information) used and analysed during the study will be available to researchers one year after the publication date of the manuscript from the corresponding author on reasonable request, with the approval of the steering committee and Research Center for Clinical Trials of the Third Xiangya Hospital of Central South University, on signing of a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, PROBE Trial on Antihypertensive Drug Selection Based on Hemodynamic Phenotypes Defined by Bioelectrical Impedance Analysis
- ClinicalTrials.gov ID
- NCT07240909
- Acronym / sponsor ID
- HEMOPHENO / R25070
- Conditions
- Hypertension
- Keywords
- hypertension, anti-hypertensive therapy, Hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Nov 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.
The goal of this clinical trial is to explore the clinical efficacy and safety of individualized antihypertensive medication guided by hemodynamic phenotyping. The main questions it aims to answer are:
- Does hemodynamics-based individualized antihypertensive therapy achieve better blood pressure control compared to guideline-based conventional therapy?
- Does hemodynamics-based individualized therapy have comparable safety to guideline-based conventional treatment? Researchers will compare hemodynamics-based individualized antihypertensive therapy to guideline-based conventional treatment to see if the former is better than the latter.
Participants will:
- Take hemodynamics-based individualized antihypertensive therapy or guideline-based conventional treatment every day for 8 weeks
- Visit the clinic once every 4 weeks for checkups and tests
- Keep a diary of their symptoms and any treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hemodynamics-based individualized antihypertensive therapy | Experimental | Drug: hemodynamics-based individualized antihypertensive therapyThe antihypertensive strategy is individualized according to the patient's hemodynamic indices: High-resistance type: Amlodipine Besylate Tablets 5mg, once daily, orally. High cardiac output type: Metoprolol Sustained-Release Tablets 47.5mg, once daily, orally. Hypervolemic type: Indapamide Tablets 2.5mg, once daily, orally. |
| guideline-based conventional therapy | Active comparator | Drug: guideline-based conventional treatmentDeveloping a monotherapy antihypertensive treatment plan for participants based on the 2024 Chinese hypertension guidelines |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥30 and <80 years, regardless of gender;
- Confirmed diagnosis of hypertension meeting the criteria outlined in the 2024 Chinese Hypertension Guidelines: office blood pressure ≥140/90 mmHg and home blood pressure ≥135/85 mmHg;
- Mild to moderate hypertension, with office blood pressure ranging from 140-179/90-109 mmHg;
- No prior use of antihypertensive medications;
- Voluntary participation in the study with written informed consent obtained.
Key exclusion criteria (16 listed)
- Diagnosed or highly suspected secondary hypertension;
- Classified as mixed type according to hemodynamic typing;
- Allergy to the intended antihypertensive medications;
- Dysphagia;
- Pregnant or lactating women;
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 |
|---|---|---|
| hemodynamics-based individualized antihypertensive therapyAlso: individualized therapyThe antihypertensive strategy is individualized according to the patient's hemodynamic indices: High-resistance type: Amlodipine Besylate Tablets 5mg, once daily, orally. High cardiac output type: Metoprolol Sustained-Release Tablets 47.5mg, once daily, orally. Hypervolemic type: Indapamide Tablets 2.5mg, once daily, orally. Participants will take the therapy for 8 weeks. | Drug | hemodynamics-based individualized antihypertensive therapy |
| guideline-based conventional treatmentAlso: conventional treatmentDeveloping a monotherapy antihypertensive treatment plan for participants based on the 2024 Chinese hypertension guidelines. Participants will take this treatment for 8 weeks. | Drug | guideline-based conventional therapy |
Primary outcome
Difference in office systolic blood pressure reduction
Time frame: 8 weeks after treatment
Difference in office systolic blood pressure reduction between two groups.
15 secondary outcomes
Reduction difference in office systolic blood pressure
Time frame: 4 weeks after treatment
Reduction difference in office diastolic blood pressure
Time frame: 4 weeks after treatment
Reduction difference in office mean blood pressure
Time frame: 4 weeks after treatment
Difference in pulse rate changes
Time frame: 4 weeks after treatment
Difference in blood pressure target rate
Time frame: 4 weeks after treatment
Difference of systemic vascular resistance index (SVRI) changes
Time frame: 4 weeks after treatment
Difference of cardiac index (CI) changes
Time frame: 4 weeks after treatment
Difference of thoracic fluid content (TFC) changes
Time frame: 4 weeks after treatment
Reduction difference in office diastolic blood pressure
Time frame: 8 weeks after treatment
Reduction difference in office mean blood pressure
Time frame: 8 weeks after treatment
Difference in pulse rate changes
Time frame: 8 weeks after treatment
Difference in blood pressure target rate
Time frame: 8 weeks after treatment
Difference of systemic vascular resistance index (SVRI) changes
Time frame: 8 weeks after treatment
Difference of cardiac index (CI) changes
Time frame: 8 weeks after treatment
Difference of thoracic fluid content (TFC) changes
Time frame: 8 weeks after treatment
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 21 Nov 2025.
- Individual participant dataSharing planned: Yes. Coded data (without personal identification information) used and analysed during the study will be available to researchers one year after the publication date of the manuscript from the corresponding author on reasonable request, with the approval of the steering committee and Research Center for Clinical Trials of the Third Xiangya Hospital of Central South University, on signing of a data access agreement.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hemodynamics-based individualized antihypertensive therapy and guideline-based conventional treatment in people with Hypertension, run by The Third Xiangya Hospital of Central South University.
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 5 inclusion and 16 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 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in office systolic blood pressure reduction (time frame: 8 weeks after treatment). 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 21 Nov 2025.