Management of Albuminuria in Hypertensive Diabetics

Hypertension Clinical Trial

— CLINPRADIA  

Official title:

A Multicentre Study to Evaluate the Management of Microalbuminuria in Hypertensive Patients With Type 2 Diabetes: Improving Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01907958
• Other study ID #: CLINPRADIA
• Status: Recruiting
• Phase: N/A
• First received: July 18, 2013
• Last updated: July 24, 2013
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: July 2013
• Source: Medpharmgene, Inc.
• Contact: Marie-Renée GUERTIN, project manager
• Phone: 514 249 4209
• Email: m-r.guertin[@]medpharmgene.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Multicenter stepped wedge cluster randomized trial of family practice clinics in Quebec and Ontario comparing the effect of introducing a Point of Care testing (POCT) for urine albumin to usual practice on quality of care in hypertensive patients with Type 2 diabetes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female 18 years and older and able to visit the study sites every 3 months

• T2D patients with ongoing anti-diabetic therapy for at least 5 years

• Uncontrolled hypertension according to 2012 CHEP recommendations for management of hypertension in diabetic patients ( i.e. BP> 130/80 mmHg)

• Able and agreeing to provide informed consent.

Exclusion Criteria:

• Type 1 diabetes patients

• Ongoing therapy with perindopril,

• Known hypersensitivity or allergies to ACEI or sulfonamide derivatives,

• A history of angioedema related or not to previous treatment with ACEI,

• Impaired renal function defined as serum creatinine levels > 177 µmol/L, eGFR <30 mL/min,

• Hyperkalemia or hypokalemia,

• Severe hepatic impairment,

• Use of non-antiarrhythmic agents causing torsade de pointes,

• Pregnant or lactating women, or who are planning to become pregnant,

• Any conditions which may impact on participation according to treating physician.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus, Type 2
• Hypertension
• Microalbuminuria
• Type 2 Diabetes

Locations

Country	Name	City	State
Canada	Medpharmgene	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Medpharmgene, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics, medical history and medication Diabetes and hypertension status Blood pressure measurements		12 months	No
Primary	Stabilisation or improvement of urine albumin excretion status by at least one stage		1 year	No
Secondary	Microalbuminuria (or further stages of CKD) after 12 months		12 months	No