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
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Condition or disease |
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Hypertension |
- 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 |
Estimated Enrollment : | 200 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension (BETTER-HTN) |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | January 2011 |
Estimated Study Completion Date : | June 2011 |

Group/Cohort |
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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.
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- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00913094
United States, Michigan | |
Wayne State University | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Mary Maysura 313-745-2378 | |
Principal Investigator: John Flack, MD |
Principal Investigator: | John M Flack, MD | Wayne State University, and Detroit Medical Center |
Responsible Party: | Rhonda Rhyne, President, CardioDynamics |
ClinicalTrials.gov Identifier: | NCT00913094 |
Other Study ID Numbers: |
07001-M2-1-2-3 |
First Posted: | June 3, 2009 Key Record Dates |
Last Update Posted: | June 11, 2009 |
Last Verified: | June 2009 |
Hypertension |
Hypertension Vascular Diseases Cardiovascular Diseases |