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Heart FailureCOMPASSNCT07252856

Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

A study testing DEEPER in people with Heart Failure and Myocardial Infarction, run by Fondazione Don Carlo Gnocchi ETS at 6 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Myocardial Infarction
What is being tested?
DEEPER
Could I receive a placebo?
No, everyone receives an active treatment
How many people
306 participants
Where
6 sitesin 4 countries
Study dates
20 Apr 2026to 31 Jul 2027
Phase
Interventional
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

Who may be able to join

  • Age ≥ 18, men and women;
  • patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure);
  • patients who completed phase II CR and are therefore eligible for CR phase III (maintenance).

Who cannot join

  • Unable to sign the informed consent;
  • unable or unwilling to use digital devices due to mental/cognitive issues or without a support person helping them to access the respective technical devices;
  • pregnant, lactating or women planning pregnancy during the course of the trial.

Trial locations and contacts

6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Nuccia Morici, MD contact

00390240308519

nmorici@dongnocchi.it

Anastasia Toccafondi contact

atoccafondi@dongnocchi.it

6 sites in 4 countries

Italy3 sites, 3 recruiting

  • Carlo Cattaneo - LIUC University

    Castellanza

    Emanuela Foglia

    Not yet recruiting

  • Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane

    Lumezzane

    Simonetta Scalvini

    Recruiting

  • IRCCS Dongnocchi

    Milan, 20148

    Nuccia Morici, Medicine, 3206359064, nmorici@dongnocchi.it

    Gaia Coni, Psychology, 3203003671, nmorici@dongnocchi.it

    Recruiting

Other trials in Italy

Belgium1 site, 1 recruiting

  • KU Leuven, Kaatje Goetschalckx, KU Leuven

    Leuven

    Véronique Cornelissen

    Recruiting

Other trials in Belgium

Portugal1 site, 1 recruiting

  • Associação para Investigação e Desenvolvimento da Faculdade de Medicina - AIDFM, representing Instituto Medicina Preventiva e Saúde Public (IMPSP) & Instituto de Saúde Ambiental (ISAMB)

    Lisbon

    Ana Abreu

    Recruiting

Other trials in Portugal

Switzerland1 site, 1 recruiting

  • Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland

    Bern

    Matthias Wilhelm

    Recruiting

Other trials in Switzerland

About this study

Official title: CrOss-cultural Model for Postdischarge Assistance and Sustainable Digital Solutions in Phase III Cardiac Rehabilitation: a Randomized Controlled Trial

Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LC9) (LE8 + PHQ-9).

Read the detailed description

Multicenter Prospective Controlled Randomized Trial, open-label, in patients with atherosclerotic cardiovascular disease (ASCVD) (acute coronary syndrome or chronic coronary syndrome and ischemic heart failure) and an approved indication for cardiac rehabilitation (CR). Patients completing phase II CR will be randomized 1:1 to usual Phase-III care (standard care) versus standard care plus the Digitally-Enhanced Extended PrEvention \& Rehabilitation (DEEPER) package (intervention). Primary outcome is 6-month change in composite Life's Crucial 9 (LE9) (LE8 + PHQ-9). Intervention (DEEPER) will include informative modules (patient will choose among graphic medicine, video or interactive messaging) that will be delivered every two weeks via secure digital platform (or booklet if offline); monthly motivational messages; moderated peer-support forum with leaderboard; remote wearable step/sleep upload with personalized content assignment and feedback, linked to the hospital interactive digital platform (Rehab companion).

Patients will be encouraged to have their own device to be adopted as lifelong maintenance. Nevertheless, centres will provide a smartwatch (fitbit) to all the patients enrolled in the trial as incentive for study participation and to uniformly collect study outcomes.

Being tested
DEEPER
Medical subject headings
Heart Failure, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEEPERBehavioural

    A transcultural scientific digital platform (Rehab companion, Inselspital, University Hospital of Bern) for content delivery, feedback and digital biomarker monitoring will be made available.

Study groups in NCT07252856
Study groupRoleWhat they receive
DEEPERExperimentalAs "Standard Care" plus every 15 days in the first month and at least once a month chat with healthcare professional that will keep posted with the patient and the staff (nurse, physiotherapist, cardiologist) for all the issues raised by the patients. chat with answer within 72 hours. Graphical medicine to increase patients' awareness.
Receives: Behavioral: DEEPER
Standard of careNo interventionDischarge after phase II, LC9 evaluation, discharge indications, website indication for every country language support (from the European Society of Preventive Cardiology). FU contact by phone at 3 months, clinical visit at 6 months [6 month LE9 assessment (primary endpoint)] and contact by phone at 1 year for MACE evaluation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6-month change in composite Life's Essential 9 (LE9)

    LC9 is defined by the American Heart Association's Life's Essential 8 (LE8), complemented by the Patient Health Questionnaire (PHQ-9), collectively referred to as "LC9 [blood pressure, non-high-density lipoprotein cholesterol (HDL), diet questionnaire, physical activity, smoking habits, sleep health, body mass index (BMI), hemoglobin A1c (HbA1c, %), PHQ9 from questionnaire).

    Measured: 6-month change

Secondary outcomes (18)

  1. Individual LE8 sub-scores

    Reported as differences in the absolute value among the two groups (median and (IQR)

    Measured: 6-month change

  2. Major adverse cardiovascular event (MACE)

    defined as a composite of death of any cause, myocardial infarction, unplanned revascularization, rehospitalization for any cause, stroke, considered in a hierarchical way and as single endpoint

    Measured: 6 months

  3. Major adverse cardiovascular event (MACE)

    defined as a composite of death of any cause, myocardial infarction, unplanned revascularization, rehospitalization for any cause, stroke, considered in a hierarchical way and as single endpoint

    Measured: 1 year

  4. GAD 7

    anxiety score; Seven-item questionnaire that assesses the severity of anxiety symptoms over the past two weeks, with a total score ranging from 0 to 21

    Measured: Changes between baseline and 6-month follow-up

  5. PHQ 9

    depression score; The PHQ-9 score ranges from 0 to 27. Scores between 5 and 9 indicate the presence of subthreshold depression.

    Measured: Changes between baseline and 6-month follow-up

  6. Physical fitness

    distance achieved in 6-minute walking test

    Measured: Changes between baseline and 6-month follow-up

  7. VO2 peak

    cardiopulmonary test (CPET)

    Measured: Changes between baseline and 6-month follow-up

  8. 30 second sit-to -stand test

    number of times the patient stands in 30 seconds

    Measured: Changes between baseline and 6-month follow-up

  9. Hand-grip strength

    maximum voluntary muscle strength measured by dynamometer

    Measured: Changes between baseline and 6-month follow-up

  10. Steps per day

    amount of steps during the day

    Measured: Changes between baseline and 6-month follow-up

  11. Waist circumference

    Waist circumference in cm

    Measured: Changes between baseline and 6-month follow-up

  12. counter movement jump test.

    Maximum power measured by dynamometer; difference in the absolute value among the two groups

    Measured: Changes between baseline and 6-month follow-up

  13. Compliance with study treatment

    Compliance with study treatment defined as number (percentage) of patients who will attend the sessions provided and will complete the study.

    Measured: 6 months

  14. Economic impact of the CR pathways and financial sustainability: standard care versus stardard care plus the DEEPER package

    Direct costs of the two pathways, estimated using Activity Based Costing and financial sustainability measured with a budget impact analysis (BIA). Results reported as mean difference and standard deviation (SD) between groups.

    Cost per patient and cost-effectiveness ratio will be calculated per group of treatment.

    Measured: 6 months

  15. Acceptance of the usual care and the DEEPER package pathway using the Service User Technology Acceptance Questionnaire (SUTAQ) average values

    Responses to SUTAQ-based questionnaire administered to patients involved in the study, analyzed through a seven items scale scoring. Results reported as mean, p-value and linear regression models for enhanced care, increased accessibility, privacy and discomfort, care personnel concerns, telerehabilitation as substitution and satisfaction.

    Measured: 6 months

  16. Assessment of social, ethical and equity dimensions.

    Perceptions reported by the patients, measured with a seven item Likert scale structured questionnaire based on the EUnetHTA Core Model dimensions, comparing standard care versus DEEPER package (mean and p-value)

    Measured: 6 months

  17. Social costs

    Analysis of the indirect and out of pocket costs as average value in case of standard care and DEEPER package, to define the social costs related to the interventions.

    Measured: 6 months

  18. Safety endpoint

    Musculo-skeletal injuries (requiring medical attention) and Arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia) requiring medical attention and an emergency room or ambulatory visit.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start20 Apr 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Type I hybrid study
Masking
None (open label)
Enrolment
306 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07252856
Sponsor's protocol ID
COMPASS
Acronym
COMPASS
Status last verified
Oct 2025
First submitted
19 Nov 2025
Last updated
30 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: COMPASS research outputs will be primarily disseminated through the Zenodo repository to guarantee persistent access. To enhance discoverability, we will implement a FAIR Data Point following the official FDP specification, initially through a self-hosted solution during the active project phase. As the ecosystem evolves, we plan to migrate this functionality to established platforms like FAIR sharing, contingent on their ability to fully support our metadata requirements for cardiac rehabilitation data.

Questions about this trial

What is this clinical trial studying?

A study testing DEEPER in people with Heart Failure and Myocardial Infarction, run by Fondazione Don Carlo Gnocchi ETS at 6 sites in 4 countries.

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 3 inclusion and 3 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy, Belgium, Portugal, Switzerland. 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, MD (00390240308519, nmorici@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6-month change in composite Life's Essential 9 (LE9) (time frame: 6-month change). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07252856.

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 30 Jun 2026.

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