Transcultural Digital Solutions in Phase III Cardiac Rehabilitation
Recruiting now · Not applicable
Conditions studied: Heart Failure, Myocardial Infarction
In brief
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).
Key facts
- Study ID
- NCT07252856
- Run by
- Fondazione Don Carlo Gnocchi ETS
- People needed
- 306
- Starts
- 2026-04-20
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-06-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- KU Leuven, Kaatje Goetschalckx, KU Leuven — Leuven, Belgium (enrolling)
- Istituti Clinici Scientifici Maugeri SpA - Società Benefit, IRCCS, Lumezzane — Lumezzane, Italy (enrolling)
- IRCCS Dongnocchi — Milan, Italy (enrolling)
- 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 (enrolling)
- Centre for Rehabilitation & Sports Medicine, Inselspital, University Hospital of Bern, Bern Switzerland — Bern, Switzerland (enrolling)
- Carlo Cattaneo - LIUC University — Castellanza, Italy
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.