SPICE 2000.
Study characteristics | ||
Methods | Multinational, multicenter, prospective DBRCT Follow‐up: 12 wks Background ACEI? No |
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Participants | N=768 patients with symptomatic CHF, due to IHD (71.5%), idiopathic dilated cardiomyopathy (15.9%), or other cause (12.6%), and history of discontinuing ACEI because of intolerance Mean age: 65.7 y Females: 31.1% NYHA Class: II–IV LVEF: <35% |
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Interventions | Candesartan, target dose 16 mg OD (n=179) Placebo (n=91) |
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Outcomes | Primary: Tolerability, defined as % of randomised population completing 12‐wk DB treatment period with candesartan 4, 8 or 16 mg Secondary: NYHA functional class; 6‐minute walk test; QoL, laboratory tests |
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Notes | Funding source: Astra Hassle, AB | |
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: "...candesartan or matching placebo." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Major cardiovascular clinical events that occurred during the study period were ascertained for all patients." |
Other bias | High risk | Funding source is manufacturer of candesartan. |