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

SPICE 2000.

Study characteristics
Methods Multinational, multicenter, prospective DBRCT
Follow‐up: 12 wks
Background ACEI? No
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%
Interventions Candesartan, target dose 16 mg OD (n=179)
Placebo (n=91)
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
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.