NCT00913094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 11, 2009

Status Verified

June 1, 2009

Enrollment Period

2 years

First QC Date

June 1, 2009

Last Update Submit

June 9, 2009

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (2)

  • To determine if ICG can predict therapeutic response to antihypertensive medications

    2009-2010

  • To confirm derivation phase of ICG prediction to therapeutic response of antihypertensive medications.

    2010-2011

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Participants will be recruited form a population of subjects presenting to a specialty hypertension clinic

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • John M Flack, MD

    Wayne State University, and Detroit Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 1, 2009

First Posted

June 3, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2011

Study Completion

June 1, 2011

Last Updated

June 11, 2009

Record last verified: 2009-06

Locations

US(1)