Management of Albuminuria in Hypertensive Diabetics

NCT ID: NCT01907958

Last Updated: 2013-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

280 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microalbuminuria Hypertension Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medpharmgene, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medpharmgene

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marie-Renée GUERTIN, project manager

Role: CONTACT

514 249 4209 ext. 222

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marie-Renée Guertin, Project manager

Role: primary

514 249 4209 ext. 222

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CLINPRADIA

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.