Cardiotoxicity in the Elderly. Comparative Clinical Trial Between Primary Versus Secondary Cardiovascular Prevention Strategies

What this Trial Is About

Researchers are evaluating two different strategies to prevent heart damage in elderly cancer patients undergoing anti-tumoral treatment. This randomized, multicenter, open-label clinical trial compares an intensive cardiovascular monitoring approach involving cardio-onco-hematology teams with the current standard practice where cardiac care is based on the onco-hematologist's criteria. The main goal is to see if the primary prevention strategy reduces overall death rates compared to the secondary prevention approach. Participants will be assigned to either the primary prevention group receiving intensive cardiovascular monitoring or the secondary prevention group following usual clinical practice. The intensive monitoring includes evaluations before chemotherapy, at three and six months, then annually for five years, comprising physical exams, EKG, echocardiograms, biomarkers, counseling on heart health, and care coordination by specialized teams. The secondary prevention group will have similar scheduled visits but cardiac care based only on the onco-hematologist's decisions. During the study, participants will undergo assessments including physical exams, heart tests, quality of life questionnaires, and performance status evaluations at set intervals over five years. Researchers will track outcomes such as all-cause mortality, cancer and cardiovascular deaths, hospitalizations due to heart or cancer complications, tumor progression, and cost-effectiveness. These measures will be evaluated at two and five years to understand the impact of the prevention strategies.

Cardiovascular Prevention Strategies in Elderly Patients With Cancer (CARTIER Clinical Trial)