Cardiac RehabCardioRehabNCT07094737
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
An observational study of Cardiac Rehab and Heart Failure, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehab, Heart Failure, Coronary Disease
- How many people
- 1,600 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Dongnocchi
Milan, 20100
Nuccia Morici, Medicine, 3206359064, nmorici@dongnocchi.it
Gaia Coni, Psychology, 3203003671, gconi@dongnocchi.it
About this study
Official title: The ITACARE-P CardioRehab Registry
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.
Read the detailed description
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:
- Describe how CR programmes are implemented across different hospitals;
- Evaluate whether patients meet recommended treatment targets (such as improved fitness, lower cholesterol in coronary patients, reduced heart-failure blood markers, and appropriate medication use);
- Identify patient groups that may need different types of care;
- Support future improvements in cardiac care services in Italy and beyond.
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.
- Conditions
- Cardiac Rehab, Heart Failure, Coronary Disease, Heart Conditions, Rehabilitation, Cardiac Rehabilitation
- Keywords
- Cardiac Rehab, Heart Failure, Coronary disease, Heart conditions, Rehabilitation, Cardiac rehabilitation, Telerehabilitation
- Medical subject headings
- Heart Failure, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cardiorehab patients | cardiological rehabilitation patients with heart conditions (heart coronary diseases and/or heart failure). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the completion of the cardiac rehabilitation program (expected average of 2 to 8 weeks).
Secondary outcomes (12)
Incidence of major adverse cardiovascular events (MACE)
Composite of cardiovascular death, recurrent myocardial infarction, stroke, and hospital readmission.
Measured: in a follow-up of 12 months.
Incidence of all-cause deaths
Describes the cumulative probability of all-cause death during the follow-up
Measured: 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
Measured: 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
Measured: From admission to discharge, and at 6 and 12 months.
Change in functional capacity 6-minute walk test (6MWT) distance (metres).
Measured: From beginning to end of the cardiac rehabilitation programme (admission to discharge).
Change in cardiorespiratory fitness: peak VO₂ on cardiopulmonary exercise testing (where performed).
Measured: From beginning to end of the cardiac rehabilitation programme (admission to discharge).
Change in physical performance: Short Physical Performance Battery (SPPB) score.
Measured: From beginning to end of the cardiac rehabilitation programme (admission to discharge).
Change in perceived health status: EQ-VAS.
Measured: Admission, Discharge, at 6 and 12 months of follow-up
Change in depressive symptoms: PHQ-9 (PHQ-2 at follow-up)
Measured: From admission to discharge, and at 6 and 12 months.
Change in anxiety symptoms: GAD-7 (GAD-2 at follow-up).
Measured: From admission to discharge, and at 6 and 12 months.
Medication adherence: MGLS-4 and rate of evidence-based pharmacological therapy.
Measured: 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.
Measured: From beginning to end of the cardiac rehabilitation programme (admission to discharge).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, ASST Crema, IRCCS Ospedale San Raffaele, IRCCS Fondazione Don Gnocchi-Firenze, Fondazione Don Gnocchi Parma, U.O.S. Riabilitazione Cardiologica Area Sud Azienda USL Toscana, S.O.D. Riabilitazione Cardiologica Azienda Ospedaliero Universitaria Careggi Firenze, UOSD Cardiologia Riabilitativa Azienda Ospedaliera San Giovanni-Addolorata, IRCCS Istituti clinici Maugeri, Istituto di Montescano, IRCCS Istituti clinici Maugeri, Istituto di Pavia, IRCCS Istituti clinici Maugeri, Istituto di Gattico-Veruno, Struttura complessa Riabilitazione Cardiologica, Casa di cura villa gemma, Cardiologia Riabilitativa Tagliacozzo, ASST Brianza, Riabilitazione del Cardiopatico, UOS Cardiologia Riabilitativa ULSS Serenissima, Ospedale Riabilitativo di Alta Specializzazione, Istituto clinico Maugeri Lumezzane, IRCCS Multimedica San Giuseppe, Milano, Fondazione Don Carlo Gnocchi Onlus, Centro S. Maria alla Pineta, Massa, Multimedica San Giuseppe Castellanza
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094737
- Sponsor's protocol ID
- CardioRehab
- Acronym
- CardioRehab
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ITACARE-P CardioRehab Registry
- ClinicalTrials.gov ID
- NCT07094737
- Acronym / sponsor ID
- CardioRehab / CardioRehab
- Conditions
- Cardiac Rehab, Heart Failure, Coronary Disease, Heart Conditions, Rehabilitation, Cardiac Rehabilitation
- Keywords
- Cardiac Rehab, Heart Failure, Coronary disease, Heart conditions, Rehabilitation, Cardiac rehabilitation, Telerehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA, ASST Crema, IRCCS Ospedale San Raffaele, IRCCS Fondazione Don Gnocchi-Firenze, Fondazione Don Gnocchi Parma, U.O.S. Riabilitazione Cardiologica Area Sud Azienda USL Toscana, S.O.D. Riabilitazione Cardiologica Azienda Ospedaliero Universitaria Careggi Firenze, UOSD Cardiologia Riabilitativa Azienda Ospedaliera San Giovanni-Addolorata, IRCCS Istituti clinici Maugeri, Istituto di Montescano, IRCCS Istituti clinici Maugeri, Istituto di Pavia, IRCCS Istituti clinici Maugeri, Istituto di Gattico-Veruno, Struttura complessa Riabilitazione Cardiologica, Casa di cura villa gemma, Cardiologia Riabilitativa Tagliacozzo, ASST Brianza, Riabilitazione del Cardiopatico, UOS Cardiologia Riabilitativa ULSS Serenissima, Ospedale Riabilitativo di Alta Specializzazione, Istituto clinico Maugeri Lumezzane, IRCCS Multimedica San Giuseppe, Milano, Fondazione Don Carlo Gnocchi Onlus, Centro S. Maria alla Pineta, Massa, Multimedica San Giuseppe Castellanza
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Describe how CR programmes are implemented across different hospitals;
- Evaluate whether patients meet recommended treatment targets (such as improved fitness, lower cholesterol in coronary patients, reduced heart-failure blood markers, and appropriate medication use);
- Identify patient groups that may need different types of care;
- Support future improvements in cardiac care services in Italy and beyond.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiorehab patients | – | –cardiological rehabilitation patients with heart conditions (heart coronary diseases and/or heart failure). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Participants Achieving Condition-Specific Therapeutic Goals
Time frame: At the completion of the cardiac rehabilitation program (expected average of 2 to 8 weeks).
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)
12 secondary outcomes
Incidence of major adverse cardiovascular events (MACE)
Time frame: in a follow-up of 12 months.
Incidence of all-cause deaths
Time frame: in a follow-up of 12 months.
Incidence of hospital readmission (all-cause and cardiovascular).
Time frame: In a follow-up of 12 months.
Risk-factor control : Blood pressure control, glycaemic control (HbA1c), smoking cessation, and physical activity level.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehab and Heart Failure, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuccia Morici, Medicine (3206359064, nmorici@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Condition-Specific Therapeutic Goals (time frame: At the completion of the cardiac rehabilitation program (expected average of 2 to 8 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.