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Clinical Trials/NCT00400582
NCT00400582CompletedPhase 4

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

Montreal Heart Institute2 sites in 1 country300 target enrollmentStarted: November 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
300
Locations
2
Primary Endpoint
BNP and NT-proBNP
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion 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.

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.

Outcomes

Primary Outcomes

BNP and NT-proBNP

Time Frame: 16 weeks

Secondary Outcomes

  • Blood pressure(16 weeks)
  • CRP(16 weeks)
  • Renin(16 weeks)
  • Aldosterone(16 weeks)
  • Insulin resistance/ glucose(16 weeks)
  • NYHA functional class(16 weeks)
  • Tolerability(16 weeks)

Investigators

Sponsor
Montreal Heart Institute
Sponsor Class
Other

Study Sites (2)

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