Clinical trial NCT00913094: Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension
Official title: Bioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension (BETTER-HTN)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: CardioDynamics
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited form a population of subjects presenting to a specialty hypertension clinic

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.

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

Primary outcomes:
measure: To determine if ICG can predict therapeutic response to antihypertensive medications
timeFrame: 2009-2010
measure: To confirm derivation phase of ICG prediction to therapeutic response of antihypertensive medications.
timeFrame: 2010-2011
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Wayne State University, and Detroit Medical Center
name: John M Flack, MD
role: PRINCIPAL_INVESTIGATOR
References: