A Pharmacogenomic Study of Candesartan in Heart Failure
Information source: Montreal Heart Institute
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Candesartan up to 32 mg daily (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Montreal Heart Institute Official(s) and/or principal investigator(s):
Michel White, MD, Principal Investigator, Affiliation: Montreal Heart Institute
Simon de Denus, B. Pharm, MSc, Principal Investigator, Affiliation: Montreal Heart Institute/ Faculty of Pharmacy, University of Montreal
Overall contact:
Lucette Whittom, RN, BSc, Phone: 514-376-3330, Ext: 3931, Email: lucette.whittom@icm-mhi.org
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.
Clinical Details
Official title: 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
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Primary outcome: BNP and NT-proBNP
Secondary outcome: Blood pressureCRP Renin Aldosterone Insulin resistance/ glucose NYHA functional class Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Lucette Whittom, RN, BSc, Phone: 514-376-3330, Ext: 3931, Email: lucette.whittom@icm-mhi.org
Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada; Recruiting
Lucette Whittom, Rn, BSc, Phone: 376-3330, Ext: 3931, Email: lucette.whittom@icm-mhi.org
Additional Information
Starting date: November 2006
Last updated: July 9, 2009
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