Table 2

 Inclusion criteria, exclusion criteria, and conditional criteria as part of the explicit falsity content (XP) of RALES experimental design. Adapted from original article published by Pitt et al20

XP argumentsObservational predicatesCriteria
X1 Patients having suffered chronic heart failure IV degree of the New York Heart Association during the six previous months.Inclusion
X2 Functional class III or IV at the moment of inclusion, diagnosed as cardiac insufficiency at least six weeks earlier.Inclusion
X3 Patients with an ejection fraction of the left ventricle below 35% during the past six months.Inclusion
X4 DiabetesExclusion
X5 Renal insufficiency or creatinine above 2.5 mg/dlExclusion
X6 Congenital cardiopathyExclusion
X7 Unstable anginaExclusion
X8 Patients with potassium >5 mm/lExclusion
X9 Hyperkalaemia historyExclusion
X10 Operable valvular diseaseExclusion
X11 Primary hepatic failureExclusion
X12 Cardiac transplant indicationExclusion
X13 Active cancer or any life threatening diseaseConditional
X14 Close laboratory monitoring during treatmentConditional (research process)
X15 Potassium supplements were not recommended, except when potassium concentrations in serum were below 3.5 mmol/lConditional (research process)
X16 Patients had to be in treatment with a loop diuretic and an angiotensin converting enzyme inhibitor if it were toleratedConditional (research process)
X17 Treatment with digitalis and vasodilators was permitted but not with potassium sparing diureticsConditional (research process)