Table 2 Main inclusion and exclusion criteria in PRADA II
INCLUSION CRITERIA | EXCLUSION CRITERIA |
|---|---|
• Age ≥ 18 years | • Systolic blood pressure < 100 mmHg |
• Women with histological evidence of invasive early breast cancer scheduled for adjuvant therapy with anti-cancer regimens that include anthracyclines | • Clear indication for ACEI, ARB or aldosterone antagonist therapy |
• Eastern Cooperative Oncology Group performance status 0–1 | • Contraindication for ACEI or ARB |
|  | • Renal failure, ie. serum creatinine greater than 133 μmol/L (1.5 mg/dl) or estimated glomerular filtration rate < 45 ml/min/1.73 m2 |
|  | • Hyperkalemia, i.e. serum potassium greater than 5.0 mmol/L |
|  | • Contraindication or inability to undergo CMR examination |
|  | • Suspected poor drug compliance |
|  | • Life expectancy < 12 months |