A Pharmacogenomic Study of Candesartan in Heart Failure

University of Montreal

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Drug: Candesartan up to 32 mg daily

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00400582

MHI 06-890

D2454L00003

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)