Hypertension
Conditions
Keywords
hypertension, anti-hypertensive therapy, Hemodynamics
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
Interventions
DRUGhemodynamics-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.
DRUGguideline-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.
Sponsors
The Third Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in office systolic blood pressure reduction | 8 weeks after treatment | Difference in office systolic blood pressure reduction between two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in pulse rate changes | 4 weeks after treatment | Difference in pulse rate changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy. |
| Difference of systemic vascular resistance index (SVRI) changes | 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. |
| Difference of cardiac index (CI) changes | 4 weeks after treatment | Difference of cardiac index (CI) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy. |
| Difference of thoracic fluid content (TFC) changes | 4 weeks after treatment | Difference of thoracic fluid content (TFC) changes between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy. |
| Reduction difference in office systolic blood pressure | 4 weeks after treatment | Reduction difference in office systolic blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy. |
| Reduction difference in office diastolic blood pressure | 4 weeks after treatment | Reduction difference in office diastolic blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy. |
| Reduction difference in office mean blood pressure | 4 weeks after treatment | Reduction difference in office mean blood pressure between two groups and among subgroups of hemodynamic phenotyping in individualized antihypertensive therapy. |
| Difference in blood pressure target rate | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug reaction | Eight weeks | Adverse drug reaction between two groups |
| Serious adverse events | Eight weeks | Serious adverse events between two groups |
| Adverse events | Eight weeks | Adverse events between two groups |
Outcome results
None listed