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Clinical Trials in Belgium / NCT07252856
Recruiting Not applicable

Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

NCT07252856 · tracked via the Priya Life Science Belgium tracker
Sponsor
Fondazione Don Carlo Gnocchi ETS
Phase
Not applicable
Started
2026-04-20
Last updated
2026-06-30

Condition(s) studied

Heart FailureMyocardial Infarction

Investigational drug(s) / intervention(s)

DEEPER

DEEPER: 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 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). 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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). Exclusion Criteria: * 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.

Primary outcome measure(s)

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

Trial sites (6)

FacilityCityRegionStatus
KU Leuven, Kaatje Goetschalckx, KU Leuven Leuven Belgium Recruiting
Carlo Cattaneo - LIUC University Castellanza Italy Not Yet Recruiting
Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane Lumezzane Italy Recruiting
IRCCS Dongnocchi Milan Italy 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 Portugal Recruiting
Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland Bern Switzerland Recruiting

More Fondazione Don Carlo Gnocchi ETS trials in Belgium

Spontaneous Eye Blinking in Disorders of Consciousness Recruiting

Other trials for the same condition

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure Recruiting
RESPONDER-HF Trial Active, not recruiting
HOPE at Heart (HOPE) of Donor Hearts After Circulatory Death (DCD) Using the XVIVO Heart Assist Transport System. Active, not recruiting
Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) Active, not recruiting
AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT Active, not 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 NCT07252856 on ClinicalTrials.gov ↗ ← All trials in Belgium