NCT00572403

Brief Summary

This research project will look at the relationship between baseline variables, and the new onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker, losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back for a 4-5 year follow up visit as part of a continuing project. We hypothesize that the new onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1 year as well as being associated with elevated left ventricular mass index. The rate of new onset microalbuminuria in non-diabetics is not established and this prospective study will provide data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 8, 2011

Status Verified

March 1, 2011

First QC Date

December 12, 2007

Last Update Submit

March 4, 2011

Conditions

Microalbuminuria

Keywords

microalbuminuriarisk factors

Outcome Measures

Primary Outcomes (1)

  • To determine risk factors related to the development of microalbuminuria.

    3 months

Secondary Outcomes (1)

  • To determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria.

    3 months

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants returning for a 4-5 year follow-up visit as part of an ongoing research project will be screened for microalbuminuria and invited to participate if they meet the appropriate criteria.

You may qualify if:

  • participation in the Double Exposure study
  • elevated microalbuminuria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Study Officials

  • Sheldon Tobe, MD, FRCPC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 13, 2007

Study Start

December 1, 2007

Study Completion

April 1, 2008

Last Updated

March 8, 2011

Record last verified: 2011-03

Locations

CA(1)