Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

NCT07252856 · tracked via the Priya Life Science Portugal 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

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)

Facility	City	Region	Status
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

Other trials for the same condition

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⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure Recruiting

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036) 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 Portugal