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A Pharmacogenomic Study of Candesartan in Heart Failure
This study is currently recruiting participants.
Verified by Montreal Heart Institute, July 2009
First Received: November 15, 2006   Last Updated: July 9, 2009   History of Changes
Sponsor: Montreal Heart Institute
Collaborator: AstraZeneca
Information provided by: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT00400582
  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 IV

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
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
Intervention Details:
    Drug: Candesartan up to 32 mg daily
    Candesartan 4 to 32 mg daily
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400582

Contacts
Contact: Lucette Whittom, RN, BSc 514-376-3330 ext 3931 lucette.whittom@icm-mhi.org

Locations
Canada, Quebec
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Lucette Whittom, Rn, BSc     376-3330 ext 3931     lucette.whittom@icm-mhi.org    
Sponsors and Collaborators
Montreal Heart Institute
AstraZeneca
Investigators
Principal Investigator: Michel White, MD Montreal Heart Institute
Principal Investigator: Simon de Denus, B. Pharm, MSc Montreal Heart Institute/ Faculty of Pharmacy, University of Montreal
  More Information

No publications provided

Responsible Party: Montreal Heart Institute ( Michel White )
Study ID Numbers: MHI 06-890, D2454L00003
Study First Received: November 15, 2006
Last Updated: July 9, 2009
ClinicalTrials.gov Identifier: NCT00400582     History of Changes
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
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Therapeutic Uses
Candesartan
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010