Risk Factors Contributing to the Development of Microalbuminuria

This study has been completed.
Sponsor:
Collaborator:
Merck Frosst Canada Ltd.
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00572403
First received: December 12, 2007
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

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.


Condition
Microalbuminuria

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors Contributing to the Development of Microalbuminuria Over a 5 Year Period

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • To determine risk factors related to the development of microalbuminuria. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: December 2007
Study Completion Date: April 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.

Criteria

Inclusion Criteria:

  • participation in the Double Exposure study
  • elevated microalbuminuria
  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: NCT00572403

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Merck Frosst Canada Ltd.
Investigators
Principal Investigator: Sheldon Tobe, MD, FRCPC Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Sheldon Tobe, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00572403     History of Changes
Other Study ID Numbers: 298-2007, IISP#P2350
Study First Received: December 12, 2007
Last Updated: March 4, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
microalbuminuria
risk factors

Additional relevant MeSH terms:
Albuminuria
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014