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临床试验/NCT00913094
NCT00913094Unknown不适用

Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension (BETTER-HTN)

CardioDynamics1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
To determine if ICG can predict therapeutic response to antihypertensive medications

研究概览

简要总结

To determine whether impedance cardiography (ICG) parameters can predict favorable or unfavorable blood pressure (BP) response and time to BP control prior to initiation or intensification of specific antihypertensive drug classes and drug combinations, independent of initial BP levels.

详细描述

  • Patients with higher vascular resistance index and/or lower arterial compliance index will lower BP faster and to a greater degree overall when receiving vasodilating agents - such as ACEI's, ARB's, dihydropyridine CCB's, direct vasodilators, and central alpha agonists.
  • Patients with an elevated cardiac index will lower BP faster and to a greater degree overall when receiving agents that reduce contractility, heart rate, or blood volume - such as beta blockers, non-dihydropyridine CCB's, and other agents that are known to reduce cardiac index.
  • Patients with an elevated thoracic fluid content or lower orthostatic change in thoracic fluid content will lower BP faster and to a greater degree overall when receiving diuretics (thiazide, loop, potassium sparing), however - one of these agents will emerge as a superior alternative to reduce BP in patients with high thoracic fluid content / low orthostatic change in thoracic fluid content.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years of age
  • Able to provide written consent
  • Meet JNC definition of hypertension
  • Lab results with 6 months for: serum creatinine, urine albumin/creatinine ratio, and at least one of the following: serum glucose, or glycated hemoglobin, or hemoglobin A1C

排除标准

  • Active cardiovascular disease (unstable angina, stage C or D heart failure, uncontrolled superventricular arrhythmia, hx of ventricular arrhythmia, stroke or TIA within 6 months, ACS within 6 months)
  • Implantation of activated ventricular pacemaker
  • Known hypersensitivity or allergy to sensor gel or adhesives
  • Skin lesions prohibiting sensor placement

结局指标

主要结局

To determine if ICG can predict therapeutic response to antihypertensive medications

时间窗: 2009-2010

To confirm derivation phase of ICG prediction to therapeutic response of antihypertensive medications.

时间窗: 2010-2011

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (1)

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