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Completed

NCT Number: NCT00400582

A Pharmacogenomic Study of Candesartan in Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Candesartan up to 32 mg daily

Drug

Candesartan 4 to 32 mg daily

Other names: Atacand

Primary outcomes

  1. BNP and NT-proBNP

    Time frame: 16 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 17, 2006
Registry last updated
Jul 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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