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Status unknownNCT00913094BETTER-HTNUpdated Jun 11, 2009

Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension

An observational study in Hypertension, sponsored by CardioDynamics. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-11.

Sponsored by CardioDynamics · Observational

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 200 is close to the median of 210 across 1,359 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

CardioDynamics is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Participants will be recruited form a population of subjects presenting to a specialty hypertension clinic

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. To determine if ICG can predict therapeutic response to antihypertensive medications

    Time frame: 2009-2010

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

    Time frame: 2010-2011

07

Study locations

1 of 1 sites recruiting
  • Wayne State University
    Detroit, Michigan 48201, United States
    • Mary Maysura · Contact · 313-745-2378
    • John Flack, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00913094
Lead sponsor
CardioDynamics
First posted
Jun 3, 2009
Start date
Jan 2009
Primary completion
Jan 2011 (estimated)
Completion
Jun 2011 (estimated)
Last update
Jun 11, 2009

Study contacts

John M Flack, MD
principal investigator · Wayne State University, and Detroit Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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