Health TrialsbyHealthPanel

Antihypertensive Drug Selection Based on Hemodynamic Phenotypes

ConditionHypertension
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-80
SponsorThe Third Xiangya Hospital of Central South University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Diagnosed or highly suspected secondary hypertension;

Classified as mixed type according to hemodynamic typing;

Allergy to the intended antihypertensive medications;

Dysphagia;

Trial design

Design model

Parallel

Treatments tested in this trial

  • hemodynamics-based individualized antihypertensive therapy

    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 treatment

    Drug

    Developing a monotherapy antihypertensive treatment plan for participants based on the 2024 Chinese hypertension guidelines. Participants will take this treatment for 8 weeks.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: hemodynamics-based individualized antihypertensive therapyExperimental treatment 1 intervention
Group B: guideline-based conventional therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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

Other outcomes

1

Adverse events

Adverse events between two groups

Time frame
Eight weeks
2

Serious adverse events

Serious adverse events between two groups

Time frame
Eight weeks
3

Adverse drug reaction

Adverse drug reaction between two groups

Time frame
Eight weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Third Xiangya Hospital of Central South University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: