Status:
COMPLETED
A Pharmacogenomic Study of Candesartan in Heart Failure
Lead Sponsor:
Montreal Heart Institute
Collaborating Sponsors:
AstraZeneca
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- Principal
- Male or female \> or = 18 years old.
- Symptomatic CHF corresponding to NYHA class II-IV symptoms for at least 4 weeks prior randomization.
- LVEF \< or = 40%
- Treatment with an optimal and stable dose of ACE inhibitor for at least 4 weeks prior to enrolment in the study.
- Principal
Exclusion
- Treatment with an ARB within 8 weeks prior to randomization.
- Known hypersensitivity to ARBs or ACE inhibitors.
- Creatinine clearance \< 30 ml/min or serum creatinine \> 221
- Current serum potassium \> or = 5.0 mmol/L or a history of marked ACE inhibitor or ARB induced hyperkalemia.
- Known bilateral renal artery stenosis.
- Current symptomatic hypotension and/or systolic B.P. \< 90 mmHg.
- Decompensated heart failure described as hospitalization or I.V. administration of medication in emergency room or heart failure clinic within 4 weeks
- Stroke, acute coronary syndrome, PCI within the last 4 weeks before randomization.
- Connective tissue disease or chronic inflammatory condition
- Acute inflammatory process such as an infection or gout attack in the last 2 weeks.
- Pregnant or lactating women or women of childbearing potential who are not protected from pregnancy by an accepted method of contraception.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00400582
Start Date
November 1 2006
End Date
April 1 2010
Last Update
July 22 2011
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8