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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by CardioDynamics.
Recruitment status was:  Recruiting
Information provided by:
CardioDynamics Identifier:
First received: June 1, 2009
Last updated: June 9, 2009
Last verified: June 2009
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension (BETTER-HTN)

Further study details as provided by CardioDynamics:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00913094

United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Mary Maysura    313-745-2378      
Principal Investigator: John Flack, MD         
Sponsors and Collaborators
Principal Investigator: John M Flack, MD Wayne State University, and Detroit Medical Center
  More Information

Responsible Party: Rhonda Rhyne, President, CardioDynamics Identifier: NCT00913094     History of Changes
Other Study ID Numbers: 07001-M2-1-2-3
Study First Received: June 1, 2009
Last Updated: June 9, 2009

Keywords provided by CardioDynamics:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on May 24, 2017