A Pharmacogenomic Study of Candesartan in Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Candesartan up to 32 mg daily
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Gene polymorphism, Candesartan, ACE inhibitors, BNP, Pharmacogenomics
Eligibility 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.
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.
Sites / Locations
- Montreal Heart Institute
Outcomes
Primary Outcome Measures
BNP and NT-proBNP
Secondary Outcome Measures
Blood pressure
CRP
Renin
Aldosterone
Insulin resistance/ glucose
NYHA functional class
Tolerability
Full Information
NCT ID
NCT00400582
First Posted
November 15, 2006
Last Updated
July 20, 2011
Sponsor
Montreal Heart Institute
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00400582
Brief Title
A Pharmacogenomic Study of Candesartan in Heart Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Montreal Heart Institute
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Gene polymorphism, Candesartan, ACE inhibitors, BNP, Pharmacogenomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Candesartan up to 32 mg daily
Other Intervention Name(s)
Atacand
Intervention Description
Candesartan 4 to 32 mg daily
Primary Outcome Measure Information:
Title
BNP and NT-proBNP
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
16 weeks
Title
CRP
Time Frame
16 weeks
Title
Renin
Time Frame
16 weeks
Title
Aldosterone
Time Frame
16 weeks
Title
Insulin resistance/ glucose
Time Frame
16 weeks
Title
NYHA functional class
Time Frame
16 weeks
Title
Tolerability
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel White, MD
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Simon de Denus, B. Pharm, MSc,PhD
Organizational Affiliation
Montreal Heart Institute/ Faculty of Pharmacy, University of Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
29701105
Citation
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.
Results Reference
derived
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A Pharmacogenomic Study of Candesartan in Heart Failure
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