Cardiogenic ShockENIGMANCT06572826
Cardiac Rehabilitation in Patients Acutely Managed for Cardiogenic Shock (ENIGMA)
An observational study of Cardiogenic Shock, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Cardiac Rehabilitation intervention
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- 31 Aug 2024to 31 Jan 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Adult, Older adult
Study population: All consecutive patients with Cardiogenic Shock (CS) will be included. The deferred consent is admitted for non-competent patients.
Who may be able to join
- All consecutive patients with a clinical diagnosis of Cardiogenic Shock.
Who cannot join
- Refusal to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Don Gnocchi
Milan, 20148
Nuccia Morici, MD, 0039 02 40308519, nmorici@dongnocchi.it
About this study
Official title: A framEwork for aN InteGrated assessMent of cArdiac Rehabilitation Programs in Patients Acutely Managed for Cardiogenic Shock - ENIGMA-shock
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.
Read the detailed description
Study Population: The study will include all consecutive Cardiogenic Shock (CS) patients from the Altshock registry. The primary outcome is all-cause death and readmission-free survival at 6 months and 1 year post-ICU discharge. Secondary outcomes include functional recovery measured by illness severity (using the Medical Research Council Scale and electromyography if needed), disease-specific PROM (Kansas City Cardiomyopathy Questionnaire), and a chronic condition PROM (Long-Term Conditions Questionnaire) at 6 months.
Sample Size: An estimated cohort of 2000 CS patients, with around 1240 survivors, will be studied. This sample allows us to detect a 10% difference in death and readmission-free survival rates between those receiving post-acute care services and those who do not, with 80% power and a 5% significance level.
Validation and Assessment: A mixed-method approach will validate the innovative care model, incorporating clinical data, health economics, and professional perceptions. Key performance indicators and a RACI matrix will guide the implementation, with a focus on short- and long-term organizational impacts, economic benefits, and healthcare professional perceptions.
Data Analysis: Quantitative variables will be analyzed using standard statistical methods, and survival analysis will compare groups using Kaplan-Meier curves and log-rank tests. Multivariable Cox models will assess the impact of post-acute care services on outcomes. Economic analyses will involve cost-effectiveness and budget impact assessments.
Rehabilitation Intervention: Post-acute care, including cardiac and neuromotor rehabilitation, is critical for CS patients to prevent complications and rehospitalization. The rehabilitation program will include respiratory physiotherapy, muscle strengthening, endurance training, cardiovascular exercises, and secondary prevention strategies. Neuromotor rehabilitation will address sarcopenia and polyneuropathies with targeted exercises and advanced technologies like robotics and FES.
Expected Outcomes: The ENIGMA project aims to improve CS patient outcomes by transforming post-acute care, reducing mortality, enhancing quality of life, and proving the cost-effectiveness and sustainability of innovative care pathways.
- Conditions
- Cardiogenic Shock
- Being tested
- Cardiac Rehabilitation intervention
- Keywords
- Cardiogenic Shock, Rehabilitation
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic Shock | Study population: All consecutive patients with a clinical diagnosis of Cardiogenic Shock enrolled in the Altshock registry will be included. Receives: Other: Cardiac Rehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause of death
Incidence of all-cause death
Measured: 1 Year
Readmission in hospital for any cause
Incidence of readmission
Measured: 1 Year
Secondary outcomes (4)
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
Measured: 6-months
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.
Measured: 6-Months
Chronic-condition PROM
standardized by the Food and Drug Administration and the Oxford Patient-Reported Outcomes Group's Long-Term Conditions Questionnaire
Measured: 6-months
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.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start31 Aug 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572826
- Sponsor's protocol ID
- ENIGMA
- Acronym
- ENIGMA
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rab T, Ratanapo S, Kern KB, Basir MB, McDaniel M, Meraj P, King SB 3rd, O'Neill W. Cardiac Shock Care Centers: JACC Review Topic of the Week. J Am Coll Cardiol. 2018 Oct 16;72(16):1972-1980. doi: 10.1016/j.jacc.2018.07.074.
PubMed 30309475Luscher TF, Thiele H. Cardiogenic shock: do we need a paradigm shift? Eur Heart J. 2024 Oct 14;45(39):4178-4180. doi: 10.1093/eurheartj/ehae425. No abstract available.
PubMed 38985011van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.
PubMed 28923988Kapur NK, Kanwar M, Sinha SS, Thayer KL, Garan AR, Hernandez-Montfort J, Zhang Y, Li B, Baca P, Dieng F, Harwani NM, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim JH, Vorovich E, Whitehead EH, Blumer V, Burkhoff D. Criteria for Defining Stages of Cardiogenic Shock Severity. J Am Coll Cardiol. 2022 Jul 19;80(3):185-198. doi: 10.1016/j.jacc.2022.04.049.
PubMed 35835491Mueller S, Winzer EB, Duvinage A, Gevaert AB, Edelmann F, Haller B, Pieske-Kraigher E, Beckers P, Bobenko A, Hommel J, Van de Heyning CM, Esefeld K, von Korn P, Christle JW, Haykowsky MJ, Linke A, Wisloff U, Adams V, Pieske B, van Craenenbroeck EM, Halle M; OptimEx-Clin Study Group. Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2021 Feb 9;325(6):542-551. doi: 10.1001/jama.2020.26812.
PubMed 33560320Molloy C, Long L, Mordi IR, Bridges C, Sagar VA, Davies EJ, Coats AJ, Dalal H, Rees K, Singh SJ, Taylor RS. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. 2024 Mar 7;3(3):CD003331. doi: 10.1002/14651858.CD003331.pub6.
PubMed 38451843Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.
PubMed 26764059Balady GJ, Ades PA, Bittner VA, Franklin BA, Gordon NF, Thomas RJ, Tomaselli GF, Yancy CW; American Heart Association Science Advisory and Coordinating Committee. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation. 2011 Dec 20;124(25):2951-60. doi: 10.1161/CIR.0b013e31823b21e2. Epub 2011 Nov 14. No abstract available.
PubMed 22082676Yang T, Li Z, Jiang L, Wang Y, Xi X. Risk factors for intensive care unit-acquired weakness: A systematic review and meta-analysis. Acta Neurol Scand. 2018 Aug;138(2):104-114. doi: 10.1111/ane.12964. Epub 2018 May 29.
PubMed 29845614Lavie CJ, Ozemek C, Carbone S, Katzmarzyk PT, Blair SN. Sedentary Behavior, Exercise, and Cardiovascular Health. Circ Res. 2019 Mar;124(5):799-815. doi: 10.1161/CIRCRESAHA.118.312669.
PubMed 30817262Aburub A, Darabseh MZ, Badran R, Shurrab AM, Amro A, Degens H. The Application of Robotics in Cardiac Rehabilitation: A Systematic Review. Medicina (Kaunas). 2024 Jul 18;60(7):1161. doi: 10.3390/medicina60071161.
PubMed 39064590Morici N, Foglia E, Ferrario L, Pedersini P, Corda M, Ravera A, Oreni LM, Cusmano I, Garatti L, Toccafondi A, Sacco A, Oliva F, Garascia A, Frea S, Pistono M, Aschieri D, Tavazzi G, Pappalardo F. ENIGMA-shock: protocol for a study framEwork for aN InteGrated assessMent of cArdiac rehabilitation programmes in patients acutely managed for cardiogenic shock. BMJ Open. 2025 Feb 12;15(2):e092790. doi: 10.1136/bmjopen-2024-092790.
PubMed 39938955
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A framEwork for aN InteGrated assessMent of cArdiac Rehabilitation Programs in Patients Acutely Managed for Cardiogenic Shock - ENIGMA-shock
- ClinicalTrials.gov ID
- NCT06572826
- Acronym / sponsor ID
- ENIGMA / ENIGMA
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic Shock, Rehabilitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- 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
- Study start
- 31 Aug 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Population: The study will include all consecutive Cardiogenic Shock (CS) patients from the Altshock registry. The primary outcome is all-cause death and readmission-free survival at 6 months and 1 year post-ICU discharge. Secondary outcomes include functional recovery measured by illness severity (using the Medical Research Council Scale and electromyography if needed), disease-specific PROM (Kansas City Cardiomyopathy Questionnaire), and a chronic condition PROM (Long-Term Conditions Questionnaire) at 6 months.
Sample Size: An estimated cohort of 2000 CS patients, with around 1240 survivors, will be studied. This sample allows us to detect a 10% difference in death and readmission-free survival rates between those receiving post-acute care services and those who do not, with 80% power and a 5% significance level.
Validation and Assessment: A mixed-method approach will validate the innovative care model, incorporating clinical data, health economics, and professional perceptions. Key performance indicators and a RACI matrix will guide the implementation, with a focus on short- and long-term organizational impacts, economic benefits, and healthcare professional perceptions.
Data Analysis: Quantitative variables will be analyzed using standard statistical methods, and survival analysis will compare groups using Kaplan-Meier curves and log-rank tests. Multivariable Cox models will assess the impact of post-acute care services on outcomes. Economic analyses will involve cost-effectiveness and budget impact assessments.
Rehabilitation Intervention: Post-acute care, including cardiac and neuromotor rehabilitation, is critical for CS patients to prevent complications and rehospitalization. The rehabilitation program will include respiratory physiotherapy, muscle strengthening, endurance training, cardiovascular exercises, and secondary prevention strategies. Neuromotor rehabilitation will address sarcopenia and polyneuropathies with targeted exercises and advanced technologies like robotics and FES.
Expected Outcomes: The ENIGMA project aims to improve CS patient outcomes by transforming post-acute care, reducing mortality, enhancing quality of life, and proving the cost-effectiveness and sustainability of innovative care pathways.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic Shock | – | Other: Cardiac Rehabilitation interventionStudy population: All consecutive patients with a clinical diagnosis of Cardiogenic Shock enrolled in the Altshock registry will be included. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with Cardiogenic Shock (CS) will be included. The deferred consent is admitted for non-competent patients.
Key inclusion criteria (1 listed)
- All consecutive patients with a clinical diagnosis of Cardiogenic Shock.
Key exclusion criteria (1 listed)
- Refusal to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Rehabilitation interventionThe 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. | Other | Cardiogenic Shock |
Primary outcome
All-cause of death
Time frame: 1 Year
Incidence of all-cause death
Readmission in hospital for any cause
Time frame: 1 Year
Incidence of readmission
4 secondary outcomes
Severity of critical illness polyneuropathy
Time frame: 6-months
Disease-specific PROM
Time frame: 6-Months
Chronic-condition PROM
Time frame: 6-months
PREMS: patient's opinion regarding their clinical service.
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Results publication: PubMed 30309475Rab T, Ratanapo S, Kern KB, Basir MB, McDaniel M, Meraj P, King SB 3rd, O'Neill W. Cardiac Shock Care Centers: JACC Review Topic of the Week. J Am Coll Cardiol. 2018 Oct 16;72(16):1972-1980. doi: 10.1016/j.jacc.2018.07.074.
- Results publication: PubMed 38985011Luscher TF, Thiele H. Cardiogenic shock: do we need a paradigm shift? Eur Heart J. 2024 Oct 14;45(39):4178-4180. doi: 10.1093/eurheartj/ehae425. No abstract available.
- Results publication: PubMed 28923988van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268. doi: 10.1161/CIR.0000000000000525. Epub 2017 Sep 18.
- Results publication: PubMed 35835491Kapur NK, Kanwar M, Sinha SS, Thayer KL, Garan AR, Hernandez-Montfort J, Zhang Y, Li B, Baca P, Dieng F, Harwani NM, Abraham J, Hickey G, Nathan S, Wencker D, Hall S, Schwartzman A, Khalife W, Li S, Mahr C, Kim JH, Vorovich E, Whitehead EH, Blumer V, Burkhoff D. Criteria for Defining Stages of Cardiogenic Shock Severity. J Am Coll Cardiol. 2022 Jul 19;80(3):185-198. doi: 10.1016/j.jacc.2022.04.049.
- Results publication: PubMed 33560320Mueller S, Winzer EB, Duvinage A, Gevaert AB, Edelmann F, Haller B, Pieske-Kraigher E, Beckers P, Bobenko A, Hommel J, Van de Heyning CM, Esefeld K, von Korn P, Christle JW, Haykowsky MJ, Linke A, Wisloff U, Adams V, Pieske B, van Craenenbroeck EM, Halle M; OptimEx-Clin Study Group. Effect of High-Intensity Interval Training, Moderate Continuous Training, or Guideline-Based Physical Activity Advice on Peak Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Clinical Trial. JAMA. 2021 Feb 9;325(6):542-551. doi: 10.1001/jama.2020.26812.
- Results publication: PubMed 38451843Molloy C, Long L, Mordi IR, Bridges C, Sagar VA, Davies EJ, Coats AJ, Dalal H, Rees K, Singh SJ, Taylor RS. Exercise-based cardiac rehabilitation for adults with heart failure. Cochrane Database Syst Rev. 2024 Mar 7;3(3):CD003331. doi: 10.1002/14651858.CD003331.pub6.
- Results publication: PubMed 26764059Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.
- Results publication: PubMed 22082676Balady GJ, Ades PA, Bittner VA, Franklin BA, Gordon NF, Thomas RJ, Tomaselli GF, Yancy CW; American Heart Association Science Advisory and Coordinating Committee. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation. 2011 Dec 20;124(25):2951-60. doi: 10.1161/CIR.0b013e31823b21e2. Epub 2011 Nov 14. No abstract available.
- Results publication: PubMed 29845614Yang T, Li Z, Jiang L, Wang Y, Xi X. Risk factors for intensive care unit-acquired weakness: A systematic review and meta-analysis. Acta Neurol Scand. 2018 Aug;138(2):104-114. doi: 10.1111/ane.12964. Epub 2018 May 29.
- Results publication: PubMed 30817262Lavie CJ, Ozemek C, Carbone S, Katzmarzyk PT, Blair SN. Sedentary Behavior, Exercise, and Cardiovascular Health. Circ Res. 2019 Mar;124(5):799-815. doi: 10.1161/CIRCRESAHA.118.312669.
- Results publication: PubMed 39064590Aburub A, Darabseh MZ, Badran R, Shurrab AM, Amro A, Degens H. The Application of Robotics in Cardiac Rehabilitation: A Systematic Review. Medicina (Kaunas). 2024 Jul 18;60(7):1161. doi: 10.3390/medicina60071161.
- Derived from this study: PubMed 39938955Morici N, Foglia E, Ferrario L, Pedersini P, Corda M, Ravera A, Oreni LM, Cusmano I, Garatti L, Toccafondi A, Sacco A, Oliva F, Garascia A, Frea S, Pistono M, Aschieri D, Tavazzi G, Pappalardo F. ENIGMA-shock: protocol for a study framEwork for aN InteGrated assessMent of cArdiac rehabilitation programmes in patients acutely managed for cardiogenic shock. BMJ Open. 2025 Feb 12;15(2):e092790. doi: 10.1136/bmjopen-2024-092790.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nuccia Morici, MD (00390240308122, nmorici@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause of death (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06572826, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.