Skip to main content

Table 2 Exclusion criteria

From: FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial

 Secondary or malignant hypertension
 Inter-arm BP difference: SBP > 20 mmHg or DBP > 10 mmHg
 Symptomatic orthostatic hypotension
 Cardiovascular history
  MI, congestive heart failure (NYHA class III or IV), CABG, PTCA, or angina < 3 months before enrollment
  Severe cerebrovascular disease (stroke, cerebral infarction, or cerebral hemorrhage)
  Arrhythmia (significant ventricular tachycardia, atrial fibrillation, or atrial flutter)
  Significant valvular disease: aortic stenosis or mitral stenosis
  Hypertrophic cardiomyopathy
 Type 1 DM or HbA1c > 9% at screening
 Significant renal or hepatic disease
  Dialysis, cirrhosis, biliary tract obstruction, cholestasis, or liver failure
  eGFR (MDRD) < 30 mL/min/1.73 m2, hyperkalemia (>5.5 mmol/L) or hypokalemia (<3.5 mmol/L)
  AST or ALT > 3 times the upper limit of normal
 Any chronic inflammatory disease requiring chronic anti-inflammatory treatment (including rheumatoid arthritis, systemic lupus erythematosus, or connective tissue disease)
 Moderate or malignant retinopathy < 6 months before enrollment (e.g. moderate or severe non-proliferative diabetic retinopathy and proliferative diabetic retinopathy)
 Surgical or medical disease that may affect drug absorption, distribution, metabolism, or excretion
 Cancer history with current treatment or treatment within five years
 Pregnancy, childbearing potential without adequate contraception, or breast-feeding
 Previous hypersensitivity reaction to renin-angiotensin system inhibitors
 Alcohol or drug abuse within the previous two years
 Poor compliance during placebo run-in period: < 70%
  1. SBP systolic blood pressure, DBP diastolic blood pressure, MI myocardial infarction, NYHA New York Heart Association, CABG coronary artery bypass graft, PTCA percutaneous coronary angioplasty, DM diabetes mellitus, eGFR estimated glomerular filtration rate, MDRD Modification of Diet in Renal Disease, AST aspartate transaminase, ALT alanine transaminase