Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension

NCT ID: NCT00913094

Last Updated: 2009-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-06-30

Brief Summary

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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

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* 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.

Conditions

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Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICG

Group will have results blinded during observational phase of study. Results will be revealed at time of testing during the validation phase of the study.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioDynamics

INDUSTRY

Sponsor Role lead

Responsible Party

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CardioDynamics

Principal Investigators

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John M Flack, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University, and Detroit Medical Center

Locations

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Wayne State University

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Mary Maysura

Role: primary

313-745-2378

Other Identifiers

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07001-M2-1-2-3

Identifier Type: -

Identifier Source: org_study_id

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