Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension

• Conditions: Hypertension

• Registration Number: NCT00913094
• Lead Sponsor: CardioDynamics

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.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-06
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Last Update Submitted: 2009-06-09
• Last Update Posted: 2009-06-11
• Primary Completion: 2011-01
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine if ICG can predict therapeutic response to antihypertensive medications	2009-2010
To confirm derivation phase of ICG prediction to therapeutic response of antihypertensive medications.	2010-2011

Trial Locations

Locations (1)

Wayne State University; 🇺🇸 Detroit, Michigan, United States