An observational study in Cardiac Rehab, Heart Failure and Coronary Disease, sponsored by Fondazione Don Carlo Gnocchi ETS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Fondazione Don Carlo Gnocchi ETS · Observational
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.
The ITACARE-P CardioRehab Registry is a nationwide observational project conducted in Italy. It is led by the Fondazione Don Carlo Gnocchi in Milan and involves several hospitals and rehabilitation centres across the country. The main goal of the study is to better understand how cardiac rehabilitation (CR) is delivered to patients who have experienced heart-related conditions (coronary artery disease or heart failure). CR is a structured programme that includes exercise, lifestyle education, and psychological support. It is known to help patients recover faster, reduce the risk of future heart problems, lower hospital readmissions, and improve quality of life.
Despite strong recommendations from international guidelines, not all eligible patients are referred to CR, and programmes are not always delivered consistently. This study collects real-world data to:
The central idea is that systematically collecting and analysing data on patients undergoing CR can highlight what works best, help standardise care, and improve long-term outcomes for people with heart disease. Adults who recently had a qualifying heart condition are included. This is not a treatment trial, and no experimental therapies are given; the study observes what happens during standard care, and patients continue their normal rehabilitation. Information collected includes: basic personal and medical data (e.g., age, blood pressure, cholesterol); risk factors (e.g., smoking, diabetes, weight); emotional well-being and quality of life; functional capacity (e.g., exercise capacity); and medication use. Patients are contacted by telephone at 6 and 12 months after the programme to assess their health and any additional cardiac events.
There are no added risks, as the study does not modify usual care. While there are no direct personal benefits, participants may benefit from closer tracking of their health indicators, and their participation helps improve care for future patients. All personal health data are kept confidential and protected in accordance with EU data protection regulations (GDPR). A secure online system (REDCap) is used to collect and manage the data, which are pseudonymised so that individuals cannot be directly identified; only authorised staff have access, and the data are used solely for scientific and quality-improvement purposes.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Fondazione Don Carlo Gnocchi ETS is the lead sponsor of 43 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The criteria were revised on the registry on Sep 29, 2026. See what changed
Consecutive adult patients (≥18 years) with coronary artery disease and/or heart failure who are referred to and admitted to cardiac rehabilitation following an acute event, according to national eligibility criteria for early post-acute referral. Patients are enrolled across approximately 23 Italian cardiology and rehabilitation centres participating in the ITACARE-P network, in inpatient, outpatient, or Complex Outpatient Macro-Activity (MAC) settings, reflecting routine real-world clinical practice. The population includes complex and often under-represented subgroups (e.g., older, frail, or cognitively impaired patients) who meet referral criteria and provide written informed consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
Exclusion Criteria
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
cardiological rehabilitation patients with heart conditions (heart coronary diseases and/or heart failure).
Proportion of Participants Achieving Condition-Specific Therapeutic Goals
This composite outcome measures the proportion of participants who achieve either of the following condition-specific goals: an LDL-C target of \<55 mg/dL in patients with Coronary Artery Disease (CAD), OR a ≥30% reduction from baseline in NT-proBNP (or BNP) levels in patients with Heart Failure (HF)
Time frame: At the completion of the cardiac rehabilitation program (expected average of 2 to 8 weeks).
Incidence of major adverse cardiovascular events (MACE)
Composite of cardiovascular death, recurrent myocardial infarction, stroke, and hospital readmission.
Time frame: in a follow-up of 12 months.
Incidence of all-cause deaths
Describes the cumulative probability of all-cause death during the follow-up
Time frame: in a follow-up of 12 months.
Incidence of hospital readmission (all-cause and cardiovascular).
Describes the cumulative probability of hospital readmission for all causes during follow-up
Time frame: In a follow-up of 12 months.
Risk-factor control : Blood pressure control, glycaemic control (HbA1c), smoking cessation, and physical activity level.
Describes the change in relevant risk factors
Time frame: From admission to discharge, and at 6 and 12 months.
Change in functional capacity 6-minute walk test (6MWT) distance (metres).
Time frame: From beginning to end of the cardiac rehabilitation programme (admission to discharge).
Change in cardiorespiratory fitness: peak VO₂ on cardiopulmonary exercise testing (where performed).
Time frame: From beginning to end of the cardiac rehabilitation programme (admission to discharge).
Change in physical performance: Short Physical Performance Battery (SPPB) score.
Time frame: From beginning to end of the cardiac rehabilitation programme (admission to discharge).
Change in perceived health status: EQ-VAS.
Time frame: Admission, Discharge, at 6 and 12 months of follow-up
Change in depressive symptoms: PHQ-9 (PHQ-2 at follow-up)
Time frame: From admission to discharge, and at 6 and 12 months.
Change in anxiety symptoms: GAD-7 (GAD-2 at follow-up).
Time frame: From admission to discharge, and at 6 and 12 months.
Medication adherence: MGLS-4 and rate of evidence-based pharmacological therapy.
Time frame: At 6 and 12 months of follow-up.
CR quality indicators (EAPC): Referral to CR, time from hospital discharge to CR initiation, individualized exercise prescription, and programme completion/dropout rate.
Time frame: From beginning to end of the cardiac rehabilitation programme (admission to discharge).
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fondazione Don Carlo Gnocchi ETS