Sessa Aurunca

Researchers are evaluating the long-term clinical and instrumental response to Cardiac Contractility Modulation CCM therapy in adults with symptomatic heart failure caused by systolic left ventricular dysfunction despite adequate medical treatment. This observational cohort study, both retrospective and prospective, focuses on subjects already receiving CCM as part of their regular care. The study aims to assess clinical response, hospitalizations, quality of life, walking distance, and changes in heart biomarkers over 12 months. Participants carry the OPTIMIZER Smart Mini CCM device, a programmable implantable pulse generator connected to leads in the heart. The study groups are defined by their response to low-dose dobutamine stress echocardiography before implantation, with one group showing a reduction of 15% or more in left ventricular end-systolic volume LVESV and the other less than 15%. The low-dose dobutamine test involves incremental infusions of the drug to assess heart contractile reserve. During the 12-month follow-up, researchers will monitor changes in New York Heart Association NYHA class, hospitalizations, quality of life using the Minnesota Living with Heart Failure Questionnaire, walking test distance, and NT-proBNP biomarker levels. Additional assessments include echocardiographic measures and recording adverse events, cardiac device implants, or surgery. This comprehensive monitoring helps evaluate the clinical and functional effects of CCM therapy over time.