A Pharmacogenomic Study of Candesartan in Heart Failure

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400582

Enrollment

300

Registered

2006-11-17

Start date

2006-11-30

Completion date

2010-04-30

Last updated

2011-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart failure, Gene polymorphism, Candesartan, ACE inhibitors, BNP, Pharmacogenomics

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.

Interventions

DRUGCandesartan up to 32 mg daily

Candesartan 4 to 32 mg daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
BNP and NT-proBNP	16 weeks

Secondary

Measure	Time frame
CRP	16 weeks
Renin	16 weeks
Aldosterone	16 weeks
Blood pressure	16 weeks
NYHA functional class	16 weeks
Tolerability	16 weeks
Insulin resistance/ glucose	16 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026