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
Recruitment status was Recruiting
Sponsor:
CardioDynamics
Information provided by:
CardioDynamics
ClinicalTrials.gov Identifier:
NCT00913094
First received: June 1, 2009
Last updated: June 9, 2009
Last verified: June 2009
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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:
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
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
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 Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 03, 2015