NCT07094737

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started May 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
May 2025Dec 2027

Study Start

First participant enrolled

May 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

2.7 years

First QC Date

July 23, 2025

Last Update Submit

September 24, 2026

Conditions

Cardiac RehabHeart FailureCoronary DiseaseHeart ConditionsRehabilitationCardiac RehabilitationTelerehabilitation

Keywords

Cardiac RehabHeart FailureCoronary diseaseHeart conditionsRehabilitationCardiac rehabilitationTelerehabilitation

Outcome Measures

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)

    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)

    in a follow-up of 12 months.

  • Incidence of all-cause deaths

    in a follow-up of 12 months.

  • Incidence of hospital readmission (all-cause and cardiovascular).

    In a follow-up of 12 months.

  • Risk-factor control : Blood pressure control, glycaemic control (HbA1c), smoking cessation, and physical activity level.

    From admission to discharge, and at 6 and 12 months.

  • Change in functional capacity 6-minute walk test (6MWT) distance (metres).

    From beginning to end of the cardiac rehabilitation programme (admission to discharge).

  • +7 more secondary outcomes

Study Arms (1)

cardiorehab patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Dongnocchi

Milan, 20100, Italy

RECRUITING

MeSH Terms

Conditions

Heart FailureCoronary Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular Diseases

Central Study Contacts

Nuccia Morici, Medicine

CONTACT

3206359064nmorici@dongnocchi.it

Gaia Coni, Psychology

CONTACT

3203003671gconi@dongnocchi.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

July 30, 2025

Study Start

May 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)