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. 2012 Apr 18;2012(4):CD003040. doi: 10.1002/14651858.CD003040.pub2

Tonkon 2000.

Study characteristics
Methods Multicenter, prospective DBRCT conducted in US
Follow‐up: 12 wks
Background ACEI? Yes
Participants N=109 patients ≥18 years of age with stable symptomatic CHF, due to IHD (53%), idiopathic (40%), or other cause (7%), who were already receiving stable doses of ACEI (≥6 wks) and diuretics (≥2 wks) before and throughout study
Mean age: 63.9 y
Females: 23.9%
Race (white/black/other): 82%/12%/6%
NYHA Class: II–III
LVEF: ≤40%
Interventions Irbesartan, target dose 150 mg OD (n=57)
Placebo (n=52)
Outcomes Primary: Symptom‐limited exercise tolerance time
Secondary: NYHA functional class; LVEF
Notes Funding source: Bristol‐Myers Squibb Pharmaceutical Research Institute
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding (performance bias and detection bias)
All outcomes Low risk Quote: "Double‐blind therapy was administered as capsules of irbesartan or matching placebo."
Incomplete outcome data (attrition bias)
All outcomes High risk Missing outcome data, i.e. total hospitalisations
Quote: "Data from all randomised patients were included in the safety analysis."
Other bias High risk Funding source is manufacturer of irbesartan.