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

• ClinicalTrials.gov Identifier: NCT00913094
• Recruitment Status: Unknown
• First Posted: June 3, 2009
• Last Update Posted: June 11, 2009
• Sponsor: CardioDynamics
• 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
• 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

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

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