Management of Albuminuria in Hypertensive Diabetics

NCT01907958 | Unknown

• 1 other identifier: CLINPRADIA
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microalbuminuria; Hypertension; Type 2 Diabetes

Keywords

Microalbuminuria; Hypertensive; Diabetics; urine albumin

Outcome Measures

Primary Outcomes (1)

• Stabilisation or improvement of urine albumin excretion status by at least one stage

  1 year

Secondary Outcomes (1)

• Microalbuminuria (or further stages of CKD) after 12 months

  12 months

Other Outcomes (1)

• Demographics, medical history and medication Diabetes and hypertension status Blood pressure measurements

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18 years and older Uncontrolled blood pressure Type 2 diabetes

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medpharmgene, Inc.: lead

Study Sites (1)

Medpharmgene

Montreal, Quebec, H1Y 3L1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

urine whole blood

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Marie-Renée GUERTIN, project manager

CONTACT

514 249 4209; m-r.guertin@medpharmgene.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 25, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

CA (1)