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Not yet recruitingNCT07240909HEMOPHENOUpdated Nov 21, 2025

Antihypertensive Drug Selection Based on Hemodynamic Phenotypes

A Phase 4 interventional study of hemodynamics-based individualized antihypertensive therapy and guideline-based conventional treatment in Hypertension, sponsored by The Third Xiangya Hospital of Central South University. Not yet recruiting. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by The Third Xiangya Hospital of Central South University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
01

Study 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. Does hemodynamics-based individualized antihypertensive therapy achieve better blood pressure control compared to guideline-based conventional therapy?
  2. 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:

  1. Take hemodynamics-based individualized antihypertensive therapy or guideline-based conventional treatment every day for 8 weeks
  2. Visit the clinic once every 4 weeks for checkups and tests
  3. Keep a diary of their symptoms and any treatment
02

Conditions studied

  • Hypertension

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Keywords

  • hypertension
  • anti-hypertensive therapy
  • Hemodynamics
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 240 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged ≥30 and \<80 years, regardless of gender;
  2. 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;
  3. Mild to moderate hypertension, with office blood pressure ranging from 140-179/90-109 mmHg;
  4. No prior use of antihypertensive medications;
  5. Voluntary participation in the study with written informed consent obtained.

Exclusion criteria

Exclusion Criteria:

  1. Diagnosed or highly suspected secondary hypertension;
  2. Classified as mixed type according to hemodynamic typing;
  3. Allergy to the intended antihypertensive medications;
  4. Dysphagia;
  5. Pregnant or lactating women;
  6. Potential pregnancy plans during the trial period;
  7. Uncorrected electrolyte disturbances;
  8. Severe organ dysfunction;
  9. Comorbid conditions leading to inaccurate blood pressure measurement;
  10. Comorbid conditions or states unsuitable for noninvasive hemodynamic measurement via bioelectrical impedance;
  11. Comorbid conditions contraindicating or requiring caution with trial medications;
  12. Comorbid conditions affecting the absorption, distribution, metabolism, or excretion of trial drugs;
  13. Concurrent or planned use of medications contraindicated or requiring caution with trial drugs;
  14. Concurrent or planned use of medications interfering with trial outcomes;
  15. Clinician's assessment deems the patient unsuitable for the trial's antihypertensive regimen;
  16. Current participation in other clinical studies that may interfere with the conduct of this trial.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    hemodynamics-based individualized antihypertensive 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.

    Drug: hemodynamics-based individualized antihypertensive therapy

  • Active comparator
    guideline-based conventional therapy

    Developing a monotherapy antihypertensive treatment plan for participants based on the 2024 Chinese hypertension guidelines

    Drug: guideline-based conventional treatment

Interventions

  • Drughemodynamics-based individualized antihypertensive 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.

    Also known as: individualized therapy

  • Drugguideline-based 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.

    Also known as: conventional treatment

06

What researchers measure

Primary outcomes

  1. Difference in office systolic blood pressure reduction

    Difference in office systolic blood pressure reduction between two groups.

    Time frame: 8 weeks after treatment

Secondary outcomes

  1. 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.

    Time frame: 4 weeks after treatment

  2. 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.

    Time frame: 4 weeks after treatment

  3. 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.

    Time frame: 4 weeks after treatment

  4. Difference in pulse rate changes

    Difference in pulse rate changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

    Time frame: 4 weeks after treatment

  5. 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.

    Time frame: 4 weeks after treatment

  6. 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.

    Time frame: 4 weeks after treatment

  7. 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.

    Time frame: 4 weeks after treatment

  8. 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.

    Time frame: 4 weeks after treatment

  9. 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.

    Time frame: 8 weeks after treatment

  10. 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.

    Time frame: 8 weeks after treatment

  11. Difference in pulse rate changes

    Difference in pulse rate changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy

    Time frame: 8 weeks after treatment

  12. 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

    Time frame: 8 weeks after treatment

  13. 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.

    Time frame: 8 weeks after treatment

  14. 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.

    Time frame: 8 weeks after treatment

  15. 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.

    Time frame: 8 weeks after treatment

Other outcomes

  1. Adverse events

    Adverse events between two groups

    Time frame: Eight weeks

  2. Serious adverse events

    Serious adverse events between two groups

    Time frame: Eight weeks

  3. Adverse drug reaction

    Adverse drug reaction between two groups

    Time frame: Eight weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07240909
Lead sponsor
The Third Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Nov 21, 2025
Start date
Jan 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 21, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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