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NCT Number: NCT07240909

Antihypertensive Drug Selection Based on Hemodynamic Phenotypes

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

hemodynamics-based individualized antihypertensive therapy

Drug

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.

Other names: individualized therapy

guideline-based conventional treatment

Drug

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

Participants will take this treatment for 8 weeks.

Other names: conventional treatment

Primary outcomes

  1. Difference in office systolic blood pressure reduction

    Time frame: 8 weeks after treatment

    Difference in office systolic blood pressure reduction between two groups.

Secondary outcomes

  1. Reduction difference in office systolic blood pressure

    Time frame: 4 weeks after treatment

    Reduction difference in office systolic blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  2. Reduction difference in office diastolic blood pressure

    Time frame: 4 weeks after treatment

    Reduction difference in office diastolic blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  3. Reduction difference in office mean blood pressure

    Time frame: 4 weeks after treatment

    Reduction difference in office mean blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  4. Difference in pulse rate changes

    Time frame: 4 weeks after treatment

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

  5. Difference in blood pressure target rate

    Time frame: 4 weeks after treatment

    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.

  6. Difference of systemic vascular resistance index (SVRI) changes

    Time frame: 4 weeks after treatment

    Difference of systemic vascular resistance index (SVRI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  7. Difference of cardiac index (CI) changes

    Time frame: 4 weeks after treatment

    Difference of cardiac index (CI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  8. Difference of thoracic fluid content (TFC) changes

    Time frame: 4 weeks after treatment

    Difference of thoracic fluid content (TFC) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  9. Reduction difference in office diastolic blood pressure

    Time frame: 8 weeks after treatment

    Reduction difference in office diastolic blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  10. Reduction difference in office mean blood pressure

    Time frame: 8 weeks after treatment

    Reduction difference in office mean blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  11. Difference in pulse rate changes

    Time frame: 8 weeks after treatment

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

  12. Difference in blood pressure target rate

    Time frame: 8 weeks after treatment

    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

  13. Difference of systemic vascular resistance index (SVRI) changes

    Time frame: 8 weeks after treatment

    Difference of systemic vascular resistance index (SVRI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  14. Difference of cardiac index (CI) changes

    Time frame: 8 weeks after treatment

    Difference of cardiac index (CI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

  15. Difference of thoracic fluid content (TFC) changes

    Time frame: 8 weeks after treatment

    Difference of thoracic fluid content (TFC) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy.

Other outcomes

  1. Adverse events

    Time frame: Eight weeks

    Adverse events between two groups

  2. Serious adverse events

    Time frame: Eight weeks

    Serious adverse events between two groups

  3. Adverse drug reaction

    Time frame: Eight weeks

    Adverse drug reaction between two groups

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Official study title

A Multicenter, Randomized, PROBE Trial on Antihypertensive Drug Selection Based on Hemodynamic Phenotypes Defined by Bioelectrical Impedance Analysis

Acronym: HEMOPHENO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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