A Pharmacogenomic Study of Candesartan in Heart Failure

July 20, 2011 updated by: Montreal Heart Institute

Effect of ACE Inhibitor Plus High Dose Candesartan on BNP and Inflammation in Patients With LV Dysfunction: Impact of Renin-angiotensin-aldosterone System Genetic Polymorphisms

The purpose of this study is to evaluate the impact of genetic variations on the response to candesartan in patients with heart failure who are already treated with an ACE inhibitor.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Principal Inclusion Criteria:

  1. Male or female > or = 18 years old.
  2. Symptomatic CHF corresponding to NYHA class II-IV symptoms for at least 4 weeks prior randomization.
  3. LVEF < or = 40%
  4. Treatment with an optimal and stable dose of ACE inhibitor for at least 4 weeks prior to enrolment in the study.

Principal Exclusion Criteria:

  1. Treatment with an ARB within 8 weeks prior to randomization.
  2. Known hypersensitivity to ARBs or ACE inhibitors.
  3. Creatinine clearance < 30 ml/min or serum creatinine > 221
  4. Current serum potassium > or = 5.0 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia.
  5. Known bilateral renal artery stenosis.
  6. Current symptomatic hypotension and/or systolic B.P. < 90 mmHg.
  7. Decompensated heart failure described as hospitalization or I.V. administration of medication in emergency room or heart failure clinic within 4 weeks
  8. Stroke, acute coronary syndrome, PCI within the last 4 weeks before randomization.
  9. Connective tissue disease or chronic inflammatory condition
  10. Acute inflammatory process such as an infection or gout attack in the last 2 weeks.
  11. Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BNP and NT-proBNP
Time Frame: 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 16 weeks
16 weeks
CRP
Time Frame: 16 weeks
16 weeks
Renin
Time Frame: 16 weeks
16 weeks
Aldosterone
Time Frame: 16 weeks
16 weeks
Insulin resistance/ glucose
Time Frame: 16 weeks
16 weeks
NYHA functional class
Time Frame: 16 weeks
16 weeks
Tolerability
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Michel White, MD, Montreal Heart Institute
  • Principal Investigator: Simon de Denus, B. Pharm, MSc,PhD, Montreal Heart Institute/ Faculty of Pharmacy, University of Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (Estimate)

November 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 22, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHI 06-890
  • D2454L00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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