Antihypertensive Drug Selection Based on Hemodynamic Phenotypes (HEMOPHENO)

November 16, 2025 updated by: The Third Xiangya Hospital of Central South University

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:

  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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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
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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in office systolic blood pressure reduction
Time Frame: 8 weeks after treatment
Difference in office systolic blood pressure reduction between two groups.
8 weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks after treatment
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.
4 weeks after treatment
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 weeks after treatment
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.
4 weeks after treatment
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.
4 weeks after treatment
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.
4 weeks after treatment
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.
4 weeks after treatment
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.
4 weeks after treatment
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.
8 weeks after treatment
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.
8 weeks after treatment
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
8 weeks after treatment
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
8 weeks after treatment
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.
8 weeks after treatment
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.
8 weeks after treatment
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.
8 weeks after treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Eight weeks
Adverse events between two groups
Eight weeks
Serious adverse events
Time Frame: Eight weeks
Serious adverse events between two groups
Eight weeks
Adverse drug reaction
Time Frame: Eight weeks
Adverse drug reaction between two groups
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Third Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R25070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

One year after the publication date of the manuscript.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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