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Life sciences · Observational Study
ClinicalTrials.gov · September 29, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07094737). This is a study registration, not published results. Lead sponsor: Fondazione Don Carlo Gnocchi ETS. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1600 participants (ESTIMATED). Conditions: Cardiac Rehab, Heart Failure, Coronary Disease, Heart Conditions, Rehabilitation, Cardiac Rehabilitation, Telerehabilitation. Primary outcome measures: Proportion of Participants Achieving Condition-Specific Therapeutic Goals , At the completion of the cardiac rehabilitation program (expected average of 2 to 8 weeks).. Brief summary: The ITACARE-P CardioRehab Registry is a nationwide observational study conducted in Italy and coordinated by the Fondazione Don Carlo Gnocchi in Milan. It involves multiple hospitals and rehabilitation centres across the country and aims to better understand how cardiac rehabilitation (CR) is delivered to patients recovering from heart conditions (coronary artery disease and/or heart failure). CR is a structured programme that includes exercise, lifestyle education, and psychological support, and is known to improve recovery, reduce future cardiac events, lower hospital readmissions, and enhance quality of life. Despite strong recommendations from international guidelines, not all eligible patients are referred to CR, and its delivery varies. This study collects real-world data to describe how CR programmes are implemented, evaluate whether patients meet recommended treatment targets (such as lower cholesterol in coronary patients or reduced heart-failure blood markers), assess patient outcomes, identify subgroups needing tailored care, and support improvements in cardiac care services in Italy. Adults who recently experienced a qualifying heart condition are enrolled and followed during their standard rehabilitation, without any changes to treatment. Data on medical history, risk factors, quality of life, functional capacity, and medication use are collected, with follow-up at 6 and 12 months. Participation involves no added risks, and personal health data are securely managed in accordance with EU GDPR regulations using the REDCap system. The study aims to enhance the quality, consistency, and equity of cardiac rehabilitation across the country.