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A Pharmacogenomic Study of Candesartan in Heart Failure

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ClinicalTrials.gov Identifier: NCT00400582
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : July 22, 2011
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Montreal Heart Institute

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Candesartan up to 32 mg daily Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2006
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources


Intervention Details:
    Drug: Candesartan up to 32 mg daily
    Candesartan 4 to 32 mg daily
    Other Name: Atacand


Primary Outcome Measures :
  1. BNP and NT-proBNP [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 16 weeks ]
  2. CRP [ Time Frame: 16 weeks ]
  3. Renin [ Time Frame: 16 weeks ]
  4. Aldosterone [ Time Frame: 16 weeks ]
  5. Insulin resistance/ glucose [ Time Frame: 16 weeks ]
  6. NYHA functional class [ Time Frame: 16 weeks ]
  7. Tolerability [ Time Frame: 16 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michel White, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT00400582     History of Changes
Other Study ID Numbers: MHI 06-890
D2454L00003
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: July 22, 2011
Last Verified: July 2011

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
Candesartan
Candesartan cilexetil
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors