Clinical Trial

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

Study acronym: CardioRehab
Recruiting
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Summary
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.
Trial Details
NCT Number NCT07094737
Lead Sponsor Fondazione Don Carlo Gnocchi ETS
Collaborators: Istituti Clinici Scientifici Maugeri SpA, ASST Crema, IRCCS Ospedale San Raffaele, AORN Sant'Anna e San Sebastiano - Caserta, IRCCS Fondazione Don Gnocchi-Firenze, Fondazione Don Gnocchi Parma, U.O.S. Riabilitazione Cardiologica Area Sud Azienda USL Toscana, S.O.D. Riabilitazione Cardiologica Azienda Ospedaliero Universitaria Careggi Firenze, UOSD Cardiologia Riabilitativa Azienda Ospedaliera San Giovanni-Addolorata, IRCCS Istituti clinici Maugeri, Istituto di Montescano, IRCCS Istituti clinici Maugeri, Istituto di Pavia, IRCCS Istituti clinici Maugeri, Istituto di Gattico-Veruno, Struttura complessa Riabilitazione Cardiologica, Casa di cura villa gemma, Cardiologia Riabilitativa Tagliacozzo, ASST Brianza, Riabilitazione del Cardiopatico, UOS Cardiologia Riabilitativa ULSS Serenissima, Ospedale Riabilitativo di Alta Specializzazione, Istituto clinico Maugeri Lumezzane, U.O.C. Cardiologia ASL 3 Genovese
Conditions Cardiac Rehab, Heart Failure, Coronary Disease, Heart Conditions, Rehabilitation, Cardiac Rehabilitation, Telerehabilitation
Enrollment 1,600 participants
Start Date 2025-05-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-30