Tonkon 2000.
Study characteristics | ||
Methods | Multicenter, prospective DBRCT conducted in US Follow‐up: 12 wks Background ACEI? Yes |
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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% |
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Interventions | Irbesartan, target dose 150 mg OD (n=57) Placebo (n=52) |
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Outcomes | Primary: Symptom‐limited exercise tolerance time Secondary: NYHA functional class; LVEF |
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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. |