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Recruiting Observational

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

NCT07094737 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-05-01
Last updated
2026-09-29

Condition(s) studied

Cardiac RehabHeart FailureCoronary DiseaseHeart ConditionsRehabilitationCardiac RehabilitationTelerehabilitation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria 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. 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.

Primary outcome measure(s)

  • Proportion of Participants Achieving Condition-Specific Therapeutic Goals — 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)

Trial sites (1)

FacilityCityRegionStatus
IRCCS Dongnocchi Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07094737 on ClinicalTrials.gov ↗ ← All trials in Italy