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 Onlus

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Explicit refusal to participate in the study by the patient;

Planned hospital readmission within six months after completion of the cardiac rehabilitation program.

Trial population

cardiological rehabilitation patients with heart conditions (heart coronary deseases and/or heart failure).

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

incidence of mace in cardiorehab population

Evaluate how cardiac rehabilitation (CR) is delivered across Italy and to assess its real-world effectiveness in patients recovering from major cardiovascular events such as coronary deseases or heart failure. A key focus of the study is to measure the incidence of major adverse cardiovascular events (MACE)-including cardiovascular death, recurrent myocardial infarction, stroke, and hospital readmissions-during a 12-month follow-up period.

Time frame
6 months and 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Fondazione Don Carlo Gnocchi Onlus

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborator

ASST Crema

Collaborator

IRCCS Ospedale San Raffaele

Collaborator

AORN Sant'Anna e San Sebastiano - Caserta

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

U.O.C. Cardiologia ASL 3 Genovese

Collaborator