A Pharmacogenomic Study of Candesartan in Heart Failure
This study has been completed.
Sponsor:
Montreal Heart Institute
Collaborator:
AstraZeneca
Information provided by:
Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT00400582
First received: November 15, 2006
Last updated: July 20, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Drug: Candesartan up to 32 mg daily |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Montreal Heart Institute:
Primary Outcome Measures:
- BNP and NT-proBNP [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Blood pressure [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- CRP [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Renin [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Aldosterone [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Insulin resistance/ glucose [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- NYHA functional class [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Candesartan up to 32 mg daily
Candesartan 4 to 32 mg daily
Other Name: Atacand
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Principal Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400582
Locations
| Canada, Quebec | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T 1C8 | |
Sponsors and Collaborators
Montreal Heart Institute
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 |
More Information
No publications provided
| Responsible Party: | Michel White, Montreal Heart Institute |
| ClinicalTrials.gov Identifier: | NCT00400582 History of Changes |
| Other Study ID Numbers: | MHI 06-890, D2454L00003 |
| Study First Received: | November 15, 2006 |
| Last Updated: | July 20, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Montreal Heart Institute:
|
Heart failure Gene polymorphism Candesartan |
ACE inhibitors BNP Pharmacogenomics |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases Angiotensin-Converting Enzyme Inhibitors Candesartan Candesartan cilexetil Protease Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013