Recruiting

Observational StudyBioimpedance Evaluation of Therapeutic Titration in Essential, Refractory Hypertension

Sponsor:

CardioDynamics

Code:

NCT00913094

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Hypertension

Study ID

NCT00913094

Start date

Jan, 2009

Status verified date

Jun, 2009

Completion date

Jun, 2011

Anticipated

Primary completion date

Jan, 2011

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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 ]

Central Contacts and Locations

Locations

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Mary Maysura

313-745-2378

Principal Investigator:

John Flack, MD

More Information

Sponsor

CardioDynamics

Last update posted

Jun 11, 2009

Last verified

Jun, 2009

Keywords

Hypertension

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CardioDynamics on 2009-06-11.