NCT07094737 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
| NCT ID | NCT07094737 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus |
| Condition | Cardiac Rehab |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,600 participants in total. It began in 2025-05-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07094737 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Rehab. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07094737 currently recruiting?
Yes, NCT07094737 is actively recruiting participants. Contact the research team at nmorici@dongnocchi.it for enrollment information.
Where is the NCT07094737 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07094737 clinical trial?
NCT07094737 is sponsored by Fondazione Don Carlo Gnocchi Onlus. The trial plans to enroll 1,600 participants.