NCT07094737Recruiting
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
The ITACARE-P CardioRehab Registry
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1600 (estimated)
- First submitted
- 23 Jul 2025
- Start date
- 1 May 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07094737
What you commit to
- Study type: Observational
- Planned participants: 1600
- From 1 May 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Explicit refusal to participate in the study; Indication for cardiac rehabilitation solely following isolated valvular surgery; Highly unfavourable short-term prognosis (e.g., terminal illness); Planned elective hospital readmission within six months after completion of the cardiac rehabilitation programme.
Who the study is looking for
- Adults (≥18 years) with coronary artery disease and/or heart failure following an acute event, meeting current national regulatory requirements for appropriateness of referral to cardiac rehabilitation (early post-acute referral); Admitted to an inpatient, outpatient, or Complex Outpatient Macro-Activity (MAC) cardiac rehabilitation programme, according to the clinical setting and care pathway; Provision of written informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Dongnocchi Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.