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 arguments | Observational predicates | Criteria |
|---|---|---|
| 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 | Diabetes | Exclusion |
| X5 | Renal insufficiency or creatinine above 2.5 mg/dl | Exclusion |
| X6 | Congenital cardiopathy | Exclusion |
| X7 | Unstable angina | Exclusion |
| X8 | Patients with potassium >5 mm/l | Exclusion |
| X9 | Hyperkalaemia history | Exclusion |
| X10 | Operable valvular disease | Exclusion |
| X11 | Primary hepatic failure | Exclusion |
| X12 | Cardiac transplant indication | Exclusion |
| X13 | Active cancer or any life threatening disease | Conditional |
| X14 | Close laboratory monitoring during treatment | Conditional (research process) |
| X15 | Potassium supplements were not recommended, except when potassium concentrations in serum were below 3.5 mmol/l | Conditional (research process) |
| X16 | Patients had to be in treatment with a loop diuretic and an angiotensin converting enzyme inhibitor if it were tolerated | Conditional (research process) |
| X17 | Treatment with digitalis and vasodilators was permitted but not with potassium sparing diuretics | Conditional (research process) |