NCT00400582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4 heart-failure

Timeline
Completed

Started Nov 2006

Typical duration for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

3.4 years

First QC Date

November 15, 2006

Last Update Submit

July 20, 2011

Conditions

Heart Failure

Keywords

Heart failureGene polymorphismCandesartanACE inhibitorsBNPPharmacogenomics

Outcome Measures

Primary Outcomes (1)

  • BNP and NT-proBNP

    16 weeks

Secondary Outcomes (7)

  • Blood pressure

    16 weeks

  • CRP

    16 weeks

  • Renin

    16 weeks

  • Aldosterone

    16 weeks

  • Insulin resistance/ glucose

    16 weeks

  • +2 more secondary outcomes

Interventions

Candesartan up to 32 mg dailyDRUG

Candesartan 4 to 32 mg daily

Also known as: Atacand

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Related Publications (1)

  • de Denus S, Dube MP, Fouodjio R, Huynh T, LeBlanc MH, Lepage S, Sheppard R, Giannetti N, Lavoie J, Mansour A, Provost S, Normand V, Mongrain I, Langlois M, O'Meara E, Ducharme A, Racine N, Guertin MC, Turgeon J, Phillips MS, Rouleau JL, Tardif JC, White M; CANDIID II investigators. A prospective study of the impact of AGTR1 A1166C on the effects of candesartan in patients with heart failure. Pharmacogenomics. 2018 May;19(7):599-612. doi: 10.2217/pgs-2018-0004. Epub 2018 Apr 27.

    PMID: 29701105DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

candesartan cilexetil

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michel White, MD

    Montreal Heart Institute

    PRINCIPAL INVESTIGATOR

  • Simon de Denus, B. Pharm, MSc,PhD

    Montreal Heart Institute/ Faculty of Pharmacy, University of Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2006

First Posted

November 17, 2006

Study Start

November 1, 2006

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations

CA(1)