Risk Factors Contributing to the Development of Microalbuminuria

Microalbuminuria Clinical Trial

Official title:

Risk Factors Contributing to the Development of Microalbuminuria Over a 5 Year Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572403
• Other study ID #: 298-2007
• Secondary ID: IISP#P2350
• Status: Completed
• Phase: N/A
• First received: December 12, 2007
• Last updated: March 4, 2011
• Start date: December 2007
• Est. completion date: April 2008

Study information

• Verified date: March 2011
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Description:

The primary objective of this research project is to determine risk factors related to the development of microalbuminuria. The secondary objective is to determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. Of participants returning for a 4-5 year follow up visit as part of a continuing project, we will examine the proportion that have developed microalbuminuria. Subjects found to have microalbuminuria will be offered therapy with the ARB losartan and will be followed at three months to determine if there has been a reduction in levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• participation in the Double Exposure study

• elevated microalbuminuria

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Albuminuria
• Microalbuminuria

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Merck Frosst Canada Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine risk factors related to the development of microalbuminuria.		3 months	No
Secondary	To determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria.		3 months	No