Clinical Trial

Transcultural Digital Solutions in Phase III Cardiac Rehabilitation

Study acronym: COMPASS
Recruiting
View on ClinicalTrials.gov →
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).
Protocol Amendment History 2 changes
notable Sponsor changed: Fondazione Don Carlo Gnocchi Onlus -> Fondazione Don Carlo Gnocchi ETS 2026-07-12
critical Recruitment opened 2026-07-01
Trial Details
NCT Number NCT07252856
Lead Sponsor Fondazione Don Carlo Gnocchi Onlus
Conditions Heart Failure, Myocardial Infarction
Enrollment 306 participants
Start Date 2026-04-20
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-30