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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi ETS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,600 Participants
are grouped into 1 trial group
Group A: cardiorehab patients

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Don Carlo Gnocchi ETS

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborator

ASST Crema

Collaborator

IRCCS Ospedale San Raffaele

Collaborator

IRCCS Fondazione Don Gnocchi-Firenze

Collaborator

Fondazione Don Gnocchi Parma

Collaborator

U.O.S. Riabilitazione Cardiologica Area Sud Azienda USL Toscana

Collaborator

S.O.D. Riabilitazione Cardiologica Azienda Ospedaliero Universitaria Careggi Firenze

Collaborator

UOSD Cardiologia Riabilitativa Azienda Ospedaliera San Giovanni-Addolorata

Collaborator

IRCCS Istituti clinici Maugeri, Istituto di Montescano

Collaborator

IRCCS Istituti clinici Maugeri, Istituto di Pavia

Collaborator

IRCCS Istituti clinici Maugeri, Istituto di Gattico-Veruno

Collaborator

Struttura complessa Riabilitazione Cardiologica

Collaborator

Casa di cura villa gemma

Collaborator

Cardiologia Riabilitativa Tagliacozzo

Collaborator

ASST Brianza

Collaborator

Riabilitazione del Cardiopatico

Collaborator

UOS Cardiologia Riabilitativa ULSS Serenissima

Collaborator

Ospedale Riabilitativo di Alta Specializzazione

Collaborator

Istituto clinico Maugeri Lumezzane

Collaborator

IRCCS Multimedica San Giuseppe, Milano

Collaborator

Fondazione Don Carlo Gnocchi Onlus, Centro S. Maria alla Pineta, Massa

Collaborator

Multimedica San Giuseppe Castellanza

Collaborator