Prospective, Multicenter Open Study to Evaluate Esmolol for Early Detection of Heart Problems from Cirrhosis, Diabetes Mellitus, and Cancer Treatments

What this Trial Is About

Researchers are evaluating how well esmolol echocardiography works compared to conventional echocardiography in detecting early heart problems related to type 2 diabetes, liver cirrhosis, and cancer treatments that can affect the heart. This phase 3, open, multicenter study aims to find out if esmolol can better identify subtle heart changes before symptoms appear, helping improve diagnosis for these conditions. The study includes a 10-day screening period, followed by baseline assessments and six additional visits over 36 months. Participants will undergo both conventional echocardiography and echocardiography with esmolol given through an intravenous infusion. Esmolol dosing starts with a loading dose followed by maintenance infusion, adjusted to achieve a specific heart rate reduction. Blood samples will be collected at various visits to measure biomarkers, along with routine blood tests and vital sign monitoring. Participants will be assessed regularly with imaging and laboratory tests to measure heart function, including left ventricle ejection fraction and strain, along with biomarkers linked to heart health and inflammation. The study tracks these outcomes from baseline up to 24 months, depending on the participant’s group. Safety and health status will be monitored throughout the study period, which lasts up to three years from enrollment.

Efficacy of Esmolol in the Identification of Cardiovascular Disorders by Cirrhosis, Diabetes Mellitus and Cardiotoxic Treatments