Antihypertensive Drug Selection Based on Hemodynamic Phenotypes

NCT07240909 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: R25070
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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. 1.Does hemodynamics-based individualized antihypertensive therapy achieve better blood pressure control compared to guideline-based conventional therapy?
2. 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.
3. 3.Take hemodynamics-based individualized antihypertensive therapy or guideline-based conventional treatment every day for 8 weeks
4. 4.Visit the clinic once every 4 weeks for checkups and tests
5. 5.Keep a diary of their symptoms and any treatment

Conditions

Hypertension

Keywords

hypertension; anti-hypertensive therapy; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• Difference in office systolic blood pressure reduction

  Difference in office systolic blood pressure reduction between two groups.

  8 weeks after treatment

Secondary Outcomes (15)

• Reduction difference in office systolic blood pressure

  4 weeks after treatment

• Reduction difference in office diastolic blood pressure

  4 weeks after treatment

• Reduction difference in office mean blood pressure

  4 weeks after treatment

• Difference in pulse rate changes

  4 weeks after treatment

• Difference in blood pressure target rate

  4 weeks after treatment

Other Outcomes (3)

• Adverse events

  Eight weeks

• Serious adverse events

  Eight weeks

• Adverse drug reaction

  Eight weeks

Study Arms (2)

hemodynamics-based individualized antihypertensive therapy

EXPERIMENTAL

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.

Drug: hemodynamics-based individualized antihypertensive therapy

guideline-based conventional therapy

ACTIVE COMPARATOR

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

Drug: guideline-based conventional treatment

Interventions

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.

Also known as: individualized therapy

hemodynamics-based individualized antihypertensive therapy

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.

Also known as: conventional treatment

guideline-based conventional therapy

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 21, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the publication date of the manuscript.
• Access Criteria: Coded data (without personal identification information) used and analysed during the study will be available to researchers one year after the publication date of the manuscript from the corresponding author on reasonable request, with the approval of the steering committee and Research Center for Clinical Trials of the Third Xiangya Hospital of Central South University, on signing of a data access agreement.