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

Sponsor:

Information provided by:

CardioDynamics

ClinicalTrials.gov Identifier:

NCT00913094

First received: June 1, 2009

Last updated: June 9, 2009

Last verified: June 2009

History of Changes

Purpose

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.

Condition
Hypertension


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)

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.

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


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

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

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 ClinicalTrials.gov identifier: NCT00913094

Locations


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

CardioDynamics

Investigators


Principal Investigator:	John M Flack, MD	Wayne State University, and Detroit Medical Center

More Information


Responsible Party:	Rhonda Rhyne, President, CardioDynamics
ClinicalTrials.gov 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:


Hypertension

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 25, 2017

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