Antihypertensive Drug Selection Based on Hemodynamic Phenotypes

Phase 4Not Yet RecruitingNCT07240909

The Third Xiangya Hospital of Central South University240 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

240

Conditions

Hypertension

Interventions

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Difference in office systolic blood pressure reduction

Difference in office systolic blood pressure reduction between two groups.

Time frame: 8 weeks after treatment

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 8 weeks after treatment

Difference in blood pressure target rate

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 8 weeks after treatment