Antihypertensive Drug Selection Based on Hemodynamic Phenotypes

Официальное название

A Multicenter, Randomized, PROBE Trial on Antihypertensive Drug Selection Based on Hemodynamic Phenotypes Defined by Bioelectrical Impedance Analysis

Обзор

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

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Difference in office systolic blood pressure reduction [Срок оценки: 8 weeks after treatment]

Вторичные конечные точки (12)

• Reduction difference in office systolic blood pressure [Срок оценки: 4 weeks after treatment]
• Reduction difference in office diastolic blood pressure [Срок оценки: 4 weeks after treatment]
• Reduction difference in office mean blood pressure [Срок оценки: 4 weeks after treatment]
• Difference in pulse rate changes [Срок оценки: 4 weeks after treatment]
• Difference in blood pressure target rate [Срок оценки: 4 weeks after treatment]
• Difference of systemic vascular resistance index (SVRI) changes [Срок оценки: 4 weeks after treatment]
• Difference of cardiac index (CI) changes [Срок оценки: 4 weeks after treatment]
• Difference of thoracic fluid content (TFC) changes [Срок оценки: 4 weeks after treatment]
• Reduction difference in office diastolic blood pressure [Срок оценки: 8 weeks after treatment]
• Reduction difference in office mean blood pressure [Срок оценки: 8 weeks after treatment]
• Difference in pulse rate changes [Срок оценки: 8 weeks after treatment]
• Difference in blood pressure target rate [Срок оценки: 8 weeks after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07240909 · R25070

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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