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

The recruitment status of this study is unknown because the information has not been verified recently.
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)

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
  • To confirm derivation phase of ICG prediction to therapeutic response of antihypertensive medications. [ Time Frame: 2010-2011 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by CardioDynamics:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013