Antihypertensive Drug Selection Based on Hemodynamic Phenotypes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: hemodynamics-based individualized antihypertensive therapy, guideline-based conventional treatment.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: 30 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, PROBE Trial on Antihypertensive Drug Selection Based on Hemodynamic Phenotypes Defined by Bioelectrical Impedance Analysis
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
Interventions
- 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. - 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.
Primary outcome measures
- Difference in office systolic blood pressure reduction [Time frame: 8 weeks after treatment]
Secondary outcome measures (12)
- Reduction difference in office systolic blood pressure [Time frame: 4 weeks after treatment]
- Reduction difference in office diastolic blood pressure [Time frame: 4 weeks after treatment]
- Reduction difference in office mean blood pressure [Time frame: 4 weeks after treatment]
- Difference in pulse rate changes [Time frame: 4 weeks after treatment]
- Difference in blood pressure target rate [Time frame: 4 weeks after treatment]
- Difference of systemic vascular resistance index (SVRI) changes [Time frame: 4 weeks after treatment]
- Difference of cardiac index (CI) changes [Time frame: 4 weeks after treatment]
- Difference of thoracic fluid content (TFC) changes [Time frame: 4 weeks after treatment]
- Reduction difference in office diastolic blood pressure [Time frame: 8 weeks after treatment]
- Reduction difference in office mean blood pressure [Time frame: 8 weeks after treatment]
- Difference in pulse rate changes [Time frame: 8 weeks after treatment]
- Difference in blood pressure target rate [Time frame: 8 weeks after treatment]
Eligibility criteria
Inclusion criteria
- Aged ≥30 and <80 years, regardless of gender;
- 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;
- Mild to moderate hypertension, with office blood pressure ranging from 140-179/90-109 mmHg;
- No prior use of antihypertensive medications;
- Voluntary participation in the study with written informed consent obtained.
Exclusion criteria
- Diagnosed or highly suspected secondary hypertension;
- Classified as mixed type according to hemodynamic typing;
- Allergy to the intended antihypertensive medications;
- Dysphagia;
- Pregnant or lactating women;
- Potential pregnancy plans during the trial period;
- Uncorrected electrolyte disturbances;
- Severe organ dysfunction;
- Comorbid conditions leading to inaccurate blood pressure measurement;
- Comorbid conditions or states unsuitable for noninvasive hemodynamic measurement via bioelectrical impedance;
- Comorbid conditions contraindicating or requiring caution with trial medications;
- Comorbid conditions affecting the absorption, distribution, metabolism, or excretion of trial drugs;
- Concurrent or planned use of medications contraindicated or requiring caution with trial drugs;
- Concurrent or planned use of medications interfering with trial outcomes;
- Clinician's assessment deems the patient unsuitable for the trial's antihypertensive regimen;
- Current participation in other clinical studies that may interfere with the conduct of this trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07240909 · R25070