Antihypertensive Drug Selection Based on Hemodynamic Phenotypes (HEMOPHENO)

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: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Drug: hemodynamics-based individualized antihypertensive therapy; Drug: guideline-based conventional treatment

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Difference in office systolic blood pressure reduction	Difference in office systolic blood pressure reduction between two groups.	8 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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.	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.	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.	8 weeks after treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Adverse events between two groups	Eight weeks
Serious adverse events	Serious adverse events between two groups	Eight weeks
Adverse drug reaction	Adverse drug reaction between two groups	Eight weeks

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 16, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; Hemodynamics; anti-hypertensive therapy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID 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