A Pharmacogenomic Study of Candesartan in Heart Failure

This study has been completed.
Sponsor:
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
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 14, 2014