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

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ClinicalTrials.gov Identifier: NCT00913094
Recruitment Status : Unknown
Verified June 2009 by CardioDynamics.
Recruitment status was:  Recruiting
First Posted : June 3, 2009
Last Update Posted : June 11, 2009
Sponsor:
Information provided by:
CardioDynamics

Tracking Information
First Submitted Date June 1, 2009
First Posted Date June 3, 2009
Last Update Posted Date June 11, 2009
Study Start Date January 2009
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2009)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension
Official Title Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension (BETTER-HTN)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants will be recruited form a population of subjects presenting to a specialty hypertension clinic
Condition Hypertension
Intervention Not Provided
Study Groups/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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 2, 2009)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2011
Estimated Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00913094
Other Study ID Numbers 07001-M2-1-2-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Rhonda Rhyne, President, CardioDynamics
Study Sponsor CardioDynamics
Collaborators Not Provided
Investigators
Principal Investigator: John M Flack, MD Wayne State University, and Detroit Medical Center
PRS Account CardioDynamics
Verification Date June 2009