The Italian Alliance for Cardiovascular Rehabilitation and Prevention (ITACARE-P) Registry: An Observational Study on Cardiac Rehabilitation in Patients With Coronary Disease or Heart Failure
Recruiting · NCT07094737 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione Don Carlo Gnocchi ETS
View the official record on ClinicalTrials.gov →What this trial is about
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 centers across the country and aims to better understand how cardiac rehabilitation (CR) is delivered to patients recovering from heart conditions (coronary deseases and/or heart failure). CR is a structured program 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 programs are implemented, evaluate 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 improvements, and medication use are collected, with follow-up at 6 and 12 months. Participation involves no added risks, and personal health data is securely managed according to EU GDPR regulations using the REDCap system. The study aims to enhance the quality, consistency, and equity of cardiac rehabilitation across the country.
Who can take part
Inclusion criteria
- Patients with coronary artery disease and/or heart failure who meet the current regulatory requirements for appropriateness of referral to cardiac rehabilitation are eligible for enrollment. These patients may be included regardless of whether they are referred to inpatient or outpatient cardiac rehabilitation programs, depending on the clinical setting and care pathway.
Exclusion criteria
- Explicit refusal to participate in the study by the patient;
- Planned hospital readmission within six months after completion of the cardiac rehabilitation program.
Where it is running
1 location listed.
- IRCCS Dongnocchi - Milan, Italy