Clinical Trial

Cardiac Rehabilitation in Patients Acutely Managed for Cardiogenic Shock (ENIGMA)

Study acronym: ENIGMA

Recruiting

Record status

This record was last updated October 29, 2024 (before its estimated March 31, 2026 completion). Its status may not reflect the trial's current state.

Summary

This is a prospective and retrospective multicentre study conducted under the scientific coordination of the IRCCS Fondazione Don Gnocchi and funded by the Italian Ministry of Health (PNRR-MCNT2-2023-12377767). Using the Altshock registry, the largest multicentre Cardiogenic Shock (CS) registry in Italy, which currently has registered more than 1,000 CS patients across Italy, we will recruit patients to: (1) provide a granular assessment of post-acute phase programmes, patients' functional disability, return to work and quality of life, including specific reference to gender; (2) implement specific pathways of care in the post-acute phase; (3) provide a multidimensional assessment, thus validating an innovative model in comparison with the traditional pathway, defining the potential benefits to and impact on economic efficiency and the general sustainability of this therapeutic trajectory.

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2024-08-23.

Status change: Not Yet Recruiting → Recruiting 2024-10-25

Trial Details

NCT Number	NCT06572826
Lead Sponsor	Fondazione Don Carlo Gnocchi ETS Collaborators: Ospedale Civile Ss. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, Azienda Ospedaliera Brotzu, Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy
Conditions	Cardiogenic Shock
Enrollment	2,000 participants
Start Date	2024-08-31
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2024-10-29