Active Ingredient: GADOBUTROL
Gadobutrol is a macrocyclic gadolinium-based contrast agent for MRI that demonstrates no clinically significant effect on cardiac repolarization or QTc intervals within regulatory thresholds. In an ICH E14 thorough QT crossover study in 50 healthy volunteers evaluating 0.1, 0.3, and 0.5 mmol/kg doses with moxifloxacin control, rapid injection of the highest dose induced a transient heart rate acceleration of 13.1 bpm. When accounting for physiological QT/RR hysteresis, peak baseline- and placebo-adjusted ddQTc was 7.62 ms (upper 90% CI bound 8.87 ms, strictly below the 10 ms regulatory threshold), confirming cardiac safety. Without hysteresis consideration, the highest delta QTc was significantly high : 9.91 ms (90% CI 8.01-11.81) while with hysteresis correction, these values were 7.62 ms (90% CI 6.37-8.87). Caution is key
https://doi.org/10.1111/j.1542-474x.2009.00304.x