Effect of cilobradine in cats with a first episode of congestive heart failure due to primary cardiomyopathy.

Abstract

INTRODUCTION: Heart rate (HR) is often elevated in cats with cardiomyopathies (CMPs). Pharmacologic modulation of HR may reduce cardiac morbidity and mortality. OBJECTIVES: To investigate the effects of cilobradine vs. placebo, regarding time to cardiac mortality or morbidity in cats with first episode of congestive heart failure (CHF) due to primary CMP. ANIMALS: Three hundred and sixty-seven client-owned cats with primary CMP that had presented with a first episode of CHF at 50 centers in Europe. Per-protocol population comprised 193 cats (n&#xa0;=&#xa0;89 cilobradine, n&#xa0;=&#xa0;104 placebo). An interim analysis for futility was planned. METHODS: Prospective, randomized, placebo-controlled, double-blinded, multicenter clinical trial. Primary outcome variable was the time to a composite of cardiac mortality or cardiac morbidity. RESULTS: Median time to primary outcome was 84 days (95% confidence interval [CI]: 63-219 days) in the cilobradine group (CG) and 203 days in the placebo group&#xa0;(95% CI: 145-377 days) with observed hazard ratio of 1.44, indicating a higher hazard for the CG (P&#xa0;=&#xa0;0.057). Mean HR was 28 beats per minute (bpm) lower at Day 7 (P&#xa0;<&#xa0;0.0001) and remained 29&#xa0;bpm lower at Day 360 (P&#xa0;=&#xa0;0.026) in the CG than that in the placebo group. Although the number of adverse events did not differ, there were more serious adverse events in the CG. CONCLUSIONS: Heart rate reduction by cilobradine in cats with a first episode of CHF due to primary CMP did not reduce cardiac mortality and morbidity.