NCT07094737

Brief Summary

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.

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
20mo 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 Progress36%
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

July 30, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

July 23, 2025

Last Update Submit

July 23, 2025

Conditions

Cardiac RehabHeart FailureCoronary DiseaseHeart ConditionsRehabilitationCardiac RehabilitationTelerehabilitation

Keywords

Cardiac RehabHeart FailureCoronary diseaseHeart conditionsRehabilitationCardiac rehabilitationTelerehabilitation

Outcome Measures

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.

    6 months and 12 months

Study Arms (1)

cardiorehab patients

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

Eligibility Criteria

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

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

You may qualify if:

  • 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.

You may not qualify if:

  • Explicit refusal to participate in the study by the patient;
  • Planned hospital readmission within six months after completion of the cardiac rehabilitation program.

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 Years
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

July 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)