Health TrialsbyHealthPanel

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

ConditionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorFondazione Don Carlo Gnocchi ETS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

All consecutive patients with Cardiogenic Shock (CS) will be included. The deferred consent is admitted for non-competent patients.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Cardiac Rehabilitation intervention

    Other intervention

    The cardiac rehabilitation program for post-CS patients includes respiratory physiotherapy, muscle strengthening and endurance training such as walking, treadmill exercises, and cycling, all tailored to the patient's capabilities. Cardiovascular training involves interval and continuous aerobic exercises to improve heart function. The program emphasizes secondary prevention strategies, including lifestyle changes and medication management. Neuromotor rehabilitation addresses sarcopenia and polyneuropathies through targeted exercises like balance training, gait retraining, and the use of advanced technologies like functional electrical stimulation (FES), robotic devices, and virtual/augmented reality. Cognitive-behavioral therapy (CBT) helps manage the psychological effects of severe cardiovascular events. The program also includes speech and occupational therapy, planning for home reintegration, and telerehabilitation to ensure long-term recovery.

Treatment groups

2,000 Participants
are divided into 1 treatment group
Group A: Cardiogenic Shock1 intervention

Trial outcomes

Primary outcomes

1

All-cause of death

Incidence of all-cause death

Time frame
1 Year
2

Readmission in hospital for any cause

Incidence of readmission

Time frame
1 Year

Secondary outcomes

1

Severity of critical illness polyneuropathy

Assessment using clinical evaluation (using the Medical Research Council Scale for Muscle Strength), with electromyography and nerve conduction if required

Time frame
6-months
2

Disease-specific PROM

The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a specialized tool designed to assess the health-related quality of life in patients with heart failure. It measures the physical, social, and emotional impacts of heart failure, providing insights into the effectiveness of treatments and guiding clinical decisions.

Time frame
6-Months
3

Chronic-condition PROM

standardized by the Food and Drug Administration and the Oxford Patient-Reported Outcomes Group's Long-Term Conditions Questionnaire

Time frame
6-months
4

PREMS: patient's opinion regarding their clinical service.

Patients will be questioned about the clinical service received. The items explored will be coordination and integration of care; information, communication, and education; physical comfort; emotional support; welcoming and involvement of family and friends; transition and continuity; and access to care. Patients will define every item in terms of low quality, moderate quality and high quality.

Time frame
6-months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Don Carlo Gnocchi ETS

Lead sponsor

Ospedale Civile Ss. Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

Collaborator

Azienda Ospedaliera Brotzu

Collaborator

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

Collaborator

ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy

Collaborator

Source ClinicalTrials.gov
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