Antihypertensive Drug Selection Based on Hemodynamic Phenotypes

NCT ID: NCT07240909

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief 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

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

hemodynamics-based individualized antihypertensive therapy

Intervention Type: 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.

guideline-based conventional therapy

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

Group Type: ACTIVE_COMPARATOR

guideline-based conventional treatment

Intervention Type: DRUG

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

Participants will take this treatment for 8 weeks.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

individualized therapy; conventional treatment

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

R25070

Identifier Type: -

Identifier Source: org_study_id