Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

Hypertension Clinical Trial

— DREAM3  

Official title:

Diabetes Risk Evaluation and Microalbuminuria in Saskatchewan First Nations Peoples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741702
• Other study ID #: 231-2001
• Status: Completed
• Phase: N/A
• First received: August 25, 2008
• Last updated: May 15, 2012
• Start date: September 2001
• Est. completion date: March 2003

Study information

• Verified date: May 2012
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

This randomized controlled trial was designed to assess whether a community-based treatment strategy implemented by home care nurses would be effective in controlling hypertension in First Nations people with existing hypertension and type 2 diabetes.

Description:

Two community-based strategies for controlling hypertension in First Nations people with existing hypertension and diabetes were compared. In the intervention group, a home care nurse followed a predefined treatment algorithm of pharmacologic antihypertensive therapy. In the control group, treatment decisions were made by each subject's primary care physician. The primary outcome measure was the difference between the 2 groups in teh change in systolic blood pressure after 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age>= 18 yr

• Type 2 diabetes mellitus

• Persistent hypertension (systolic pressure >= 130 mmHg, diastolic pressure >= 80 mm Hg, or both)

Exclusion Criteria:

• use of beta blocker

• women of child-bearing age not able to use a reliable method of birth control

• Connective tissue disorder

• Severe systemic or malignant disease

• Inability to follow the protocol

• Bilateral renal artery stenosis and other causes of secondary hypertension

• Serum creatinine level > 250 micromol/L

• cerebrovascular even within 6 mo

• valvular heart disease

• unstable angina

• Myocardial infarction

• Revascularization procedure within 3 mo before study recruitment

• heart failure

• cardiac arrhythmia requiring medical treatment or heart block

• active hepatic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Hypertension

Intervention

Other:
• Nurse administered treatment algorithm
Start with Irbesartan 150 mg/d; check BP in 6 wks, if BP >=130/80 mm HF, 300 mg/d irbesartan; check BP at next visit, if BP>= 130/80 mm Hg, add HCTZ 12.5 mg/d; check BP at next visit, if BP>=130/80 mm Hg, add verapamil 180 mg/d; check BP at next visit, if BP>=13/80 mm Hg, increase verapamil to 240 mg/d

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR), Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic blood pressure		12 months	No
Secondary	Change in diastolic blood pressure, change in urine albumin status and incidence of adverse events		12 months	Yes