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Clinical Trials/NCT00913094
NCT00913094
Unknown
Not Applicable

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

CardioDynamics1 site in 1 country200 target enrollmentJanuary 2009
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
CardioDynamics
Enrollment
200
Locations
1
Primary Endpoint
To determine if ICG can predict therapeutic response to antihypertensive medications
Last Updated
16 years ago

Overview

Brief Summary

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.

Detailed Description

* 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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
June 2011
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • \> 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

To determine if ICG can predict therapeutic response to antihypertensive medications

Time Frame: 2009-2010

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

Time Frame: 2010-2011

Study Sites (1)

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