Antihypertensive Drug Selection Based on Hemodynamic Phenotypes (HEMOPHENO)

Central South University

Status and phase: Not yet enrolling; Phase 4

Conditions: Hypertension

Treatments: Drug: hemodynamics-based individualized antihypertensive therapy; Drug: guideline-based conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07240909

R25070

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

hemodynamics-based individualized antihypertensive therapy

Experimental group

Description:

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.

Treatment:

Drug: hemodynamics-based individualized antihypertensive therapy

guideline-based conventional therapy

Active Comparator group

Description:

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

Treatment:

Drug: guideline-based conventional treatment