Cardiogenic ShockNCT07885618
Factors Influencing Outcomes in ECMO and Impella Patients: Metabolic and Thyroid Hormone Dynamics
An observational study of Cardiogenic Shock and Euthyroid Sick Syndrome, run by Gottsegen National Cardiovascular Institute at 1 site in Hungary.
Trial summary
This prospective, single-center, consecutive observational study evaluates clinical, metabolic, and endocrine factors influencing survival and clinical outcomes in adult patients undergoing temporary mechanical circulatory support at the Cardiovascular Intensive Care Unit of Gottsegen Gyorgy National Cardiovascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Euthyroid Sick Syndrome, Critical Illness
- How many people
- 160 participants
- Where
- 1 siteHungary
- Study dates
- 17 Aug 2026to 31 Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult (>18 years) patients admitted to the Cardiovascular Intensive Care Unit of Gottsegen Gyorgy National Cardiovascular Institute receiving temporary mechanical circulatory support via ECMO and/or Impella.
Who may be able to join
- Adult patients (age ≥ 18 years)
- Treatment with ECMO and/or Impella support
- Informed consent provided by the patients next of kin/ legal representative
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary1 site, 1 recruiting
- Recruiting
Gottsegen Gyorgy National Cardiovascular Center
Budapest, 1096
Enikő Holndonner-Kirst, MD, PhD, +36305058050, kirst.eniko@gmail.com
kirst.eniko@gmail.com
About this study
Official title: Investigation of Factors Influencing Outcomes in Patients Requiring ECMO and Impella Support, With Special Focus on Their Metabolic and Thyroid Hormone Changes (Az ECMO és Impella kezelést igénylő Betegek kimenetelét befolyásoló tényezők vizsgálata, különös Tekintettel Metabolikus és Pajzsmirigyhormon változásaikra)
This prospective, single-center, consecutive observational study evaluates clinical, metabolic, and endocrine factors influencing survival and clinical outcomes in adult patients undergoing temporary mechanical circulatory support at the Cardiovascular Intensive Care Unit of Gottsegen Gyorgy National Cardiovascular Institute.
While traditional cardiovascular risk factors in critically ill patients are well established, non-cardiovascular variables such as endocrine dysfunction, previous functional and nutritional status, metabolic parameters and clinical complications significantly impact short- and long-term outcomes.
The study consecutively enrolls all eligible adult patients admitted to the intensive care unit requiring extracorporeal membrane oxygenation (ECMO) or Impella treatment. The primary objective is to evaluate 28-day and ICU mortality, while secondary objectives include characterizing cardiac and non-cardiac complications, nutritional status changes, and hormonal dysregulations.
Read the detailed description
Temporary mechanical circulatory support, including Extracorporeal Membrane Oxygenation (ECMO) and Impella, is increasingly used in refractory cardiogenic shock and severe cardiopulmonary failure. Despite major technological advancements and the constant refinements in critical care medicine, mortality in this group remains significant. While traditional hemodynamic and cardiac parameters are known risk factors, non-cardiac parameters such as acute metabolic destabilization, alterations in the hypothalamic-pituitary axis causing endocrine dysregulations (such as euthyroid sick syndrome) and nutritional deficiency play a critical role in the patients outcomes.
The primary objective is to identify independent predictors of mortality and clinical outcomes in patients requiring ECMO or Impella support, with particular focus on dynamic changes in metabolic status and thyroid hormone axes during critical illness. This is a prospective, single-center, consecutive observational cohort study conducted in a high-volume, tertiary cardiac intensive care center. Adult patients treated with ECMO or Impella will be enrolled upon consent. Upon enrollment the following data is to be colleted:
- Medical history (previous endocrine diseases, daily medications), pre-admission functional capacity, frailty, and nutritional history obtained via relative questionnaires.
- Serial blood gas analyses, coagulation profiles, standard metabolic panels, and detailed thyroid axis hormone levels (free T3, free T4, rT3, TSH) are obtained during routine clinical care.
- Daily echocardiography measurements and invasive hemodynamic monitoring.
- Mechanical ventilation modes and respiratory data, temporary mechanical circulatory support machine settings/parameters, continuous renal replacement therapy (CRRT) / hemoperfusion details, administered infusions, drugs and detailed enteral/parenteral nutrition tracking.
High-density data collection is conducted daily while the patient stays in the Cardiovascular Intensive Care Unit. If patient management is stepped down within the Institute, routine laboratory parameters continue to be tracked until hospital discharge. Hard primary endpoints focus on 30-day all-cause mortality and overall ICU mortality. Secondary endpoints involve cardiac and non-cardiac complication rates, nutritional impairment, and endocrine hormone changes. We use the routine treatment angorithms, the study is non-interventional.
- Conditions
- Cardiogenic Shock, Euthyroid Sick Syndrome, Critical Illness
- Keywords
- ECMO, Impella, Mechanical Circulatory Support, Critical Care, Nutritional Status, Thyroid Hormones
- Medical subject headings
- Shock, Cardiogenic, Euthyroid Sick Syndromes, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU all-cause mortality
All-cause mortality during the Intensive Care Unit stay
Measured: From date of enrollment until the date of death from any cause or discharge from the Intensive Care Unit, whichever came first, assessed up to 1 year.
28 day all-cause mortality
All-cause mortality following initiation of ECMO or Impella support
Measured: From date of enrollment until the date of death from any cause, assessed up to 28 days.
Secondary outcomes (4)
Dynamic thyroid and metabolic alterations
Low-T3 syndrome and / or metabolic dysfunction identified using abnormal lab markers during the temporary mechanical circulatory support
Measured: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year.
Cardiovascular and Non-Cardiovascular complications
Incidence of major bleeding, thrombotic events, acute kidney injury, mechanical device failure, severe infections and etc. during ICU stay
Measured: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
Nutritional and malnutritional intolarence
Incidence of enteral feeding intolerance, malnutrition signs, and caloric/protein deficit during mechanical support
Measured: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
All cause in-hospital mortality
All-cause mortality during hospital stay
Measured: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start17 Aug 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Gottsegen National Cardiovascular Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885618
- Sponsor's protocol ID
- OOI RKEB00041-1/2026
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonim data will be shared upon reasonable request.
Publications
Bear DE, Ridley EJ, Daly K, De Waele E, Al Dabbous T, Karpasiti T, Stoppe C, Barrett NA. 2025 ELSO Consensus Statement for the Provision and Management of Nutrition Therapy in Critically Ill Adult Patients Requiring Extracorporeal Membrane Oxygenation. ASAIO J. 2026 Feb 1;72(2):99-110. doi: 10.1097/MAT.0000000000002657. Epub 2026 Jan 22.
PubMed 41588618Ramsey S, Shehatta AL, Ramanathan K, Shekar K, Brodie D, Diaz R, Roberts A, Cruz S, Hodgson C, Zakhary B. Extracorporeal Life Support Organization 2024 Guideline for Early Rehabilitation or Mobilization of Adult Patients on Extracorporeal Membrane Oxygenation. ASAIO J. 2025 Mar 1;71(3):187-199. doi: 10.1097/MAT.0000000000002375. Epub 2025 Jan 30.
PubMed 39883803Hiser SL, Casey K, Nydahl P, Hodgson CL, Needham DM. Intensive care unit acquired weakness and physical rehabilitation in the ICU. BMJ. 2025 Jan 27;388:e077292. doi: 10.1136/bmj-2023-077292.
PubMed 39870417Dresen E, Naidoo O, Hill A, Elke G, Lindner M, Jonckheer J, De Waele E, Meybohm P, Modir R, Patel JJ, Christopher KB, Stoppe C. Medical nutrition therapy in patients receiving ECMO: Evidence-based guidance for clinical practice. JPEN J Parenter Enteral Nutr. 2023 Feb;47(2):220-235. doi: 10.1002/jpen.2467. Epub 2022 Dec 29.
PubMed 36495215Bridges BC, Dhar A, Ramanathan K, Steflik HJ, Schmidt M, Shekar K. Extracorporeal Life Support Organization Guidelines for Fluid Overload, Acute Kidney Injury, and Electrolyte Management. ASAIO J. 2022 May 1;68(5):611-618. doi: 10.1097/MAT.0000000000001702. Epub 2022 Mar 25.
PubMed 35348527Leeuwen L, van Heijst AFJ, van Rosmalen J, de Rijke YB, Beurskens LWJE, Tibboel D, van den Akker ELT, IJsselstijn H. Changes in thyroid hormone concentrations during neonatal extracorporeal membrane oxygenation. J Perinatol. 2017 Aug;37(8):906-910. doi: 10.1038/jp.2017.56. Epub 2017 Apr 27.
PubMed 28448064Holndonner-Kirst E, Nagy A, Czobor NR, Fazekas L, Dohan O, Kertai MD, Lex DJ, Sax B, Hartyanszky I, Merkely B, Gal J, Szekely A. The Impact of l-Thyroxine Treatment of Donors and Recipients on Postoperative Outcomes After Heart Transplantation. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1629-1635. doi: 10.1053/j.jvca.2018.10.024. Epub 2018 Oct 25.
PubMed 30467031Kozdag G, Ural D, Vural A, Agacdiken A, Kahraman G, Sahin T, Ural E, Komsuoglu B. Relation between free triiodothyronine/free thyroxine ratio, echocardiographic parameters and mortality in dilated cardiomyopathy. Eur J Heart Fail. 2005 Jan;7(1):113-8. doi: 10.1016/j.ejheart.2004.04.016.
PubMed 15642542Pingitore A, Iervasi G. Thyroid (dys)function in heart failure: is it a potential target for medical treatment? Vasc Health Risk Manag. 2005;1(2):97-100. doi: 10.2147/vhrm.1.2.97.64076. No abstract available.
PubMed 17315395Pingitore A, Landi P, Taddei MC, Ripoli A, L'Abbate A, Iervasi G. Triiodothyronine levels for risk stratification of patients with chronic heart failure. Am J Med. 2005 Feb;118(2):132-6. doi: 10.1016/j.amjmed.2004.07.052.
PubMed 15694896Opasich C, Pacini F, Ambrosino N, Riccardi PG, Febo O, Ferrari R, Cobelli F, Tavazzi L. Sick euthyroid syndrome in patients with moderate-to-severe chronic heart failure. Eur Heart J. 1996 Dec;17(12):1860-6. doi: 10.1093/oxfordjournals.eurheartj.a014804.
PubMed 8960429Iervasi G, Pingitore A, Landi P, Raciti M, Ripoli A, Scarlattini M, L'Abbate A, Donato L. Low-T3 syndrome: a strong prognostic predictor of death in patients with heart disease. Circulation. 2003 Feb 11;107(5):708-13. doi: 10.1161/01.cir.0000048124.64204.3f.
PubMed 12578873Bossone E, Arcopinto M, Iacoviello M, Triggiani V, Cacciatore F, Maiello C, Limongelli G, Masarone D, Perticone F, Sciacqua A, Perrone-Filardi P, Mancini A, Volterrani M, Vriz O, Castello R, Passantino A, Campo M, Modesti PA, De Giorgi A, Monte I, Puzzo A, Ballotta A, Caliendo L, D'Assante R, Marra AM, Salzano A, Suzuki T, Cittadini A; TOSCA Investigators. Multiple hormonal and metabolic deficiency syndrome in chronic heart failure: rationale, design, and demographic characteristics of the T.O.S.CA. Registry. Intern Emerg Med. 2018 Aug;13(5):661-671. doi: 10.1007/s11739-018-1844-8. Epub 2018 Apr 4.
PubMed 29619769Mebis L, Debaveye Y, Ellger B, Derde S, Ververs EJ, Langouche L, Darras VM, Fliers E, Visser TJ, Van den Berghe G. Changes in the central component of the hypothalamus-pituitary-thyroid axis in a rabbit model of prolonged critical illness. Crit Care. 2009;13(5):R147. doi: 10.1186/cc8043. Epub 2009 Sep 11.
PubMed 19747372Van den Berghe G, de Zegher F, Baxter RC, Veldhuis JD, Wouters P, Schetz M, Verwaest C, Van der Vorst E, Lauwers P, Bouillon R, Bowers CY. Neuroendocrinology of prolonged critical illness: effects of exogenous thyrotropin-releasing hormone and its combination with growth hormone secretagogues. J Clin Endocrinol Metab. 1998 Feb;83(2):309-19. doi: 10.1210/jcem.83.2.4575.
PubMed 9467533
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Influencing Outcomes in Patients Requiring ECMO and Impella Support, With Special Focus on Their Metabolic and Thyroid Hormone Changes (Az ECMO és Impella kezelést igénylő Betegek kimenetelét befolyásoló tényezők vizsgálata, különös Tekintettel Metabolikus és Pajzsmirigyhormon változásaikra)
- ClinicalTrials.gov ID
- NCT07885618
- Acronym / sponsor ID
- OOI RKEB00041-1/2026
- Conditions
- Cardiogenic Shock, Euthyroid Sick Syndrome, Critical Illness
- Keywords
- ECMO, Impella, Mechanical Circulatory Support, Critical Care, Nutritional Status, Thyroid Hormones
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Gottsegen National Cardiovascular InstituteUniversity, hospital or other
- Study start
- 17 Aug 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 21 Oct 2026 (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 prospective, single-center, consecutive observational study evaluates clinical, metabolic, and endocrine factors influencing survival and clinical outcomes in adult patients undergoing temporary mechanical circulatory support at the Cardiovascular Intensive Care Unit of Gottsegen Gyorgy National Cardiovascular Institute.
While traditional cardiovascular risk factors in critically ill patients are well established, non-cardiovascular variables such as endocrine dysfunction, previous functional and nutritional status, metabolic parameters and clinical complications significantly impact short- and long-term outcomes.
The study consecutively enrolls all eligible adult patients admitted to the intensive care unit requiring extracorporeal membrane oxygenation (ECMO) or Impella treatment. The primary objective is to evaluate 28-day and ICU mortality, while secondary objectives include characterizing cardiac and non-cardiac complications, nutritional status changes, and hormonal dysregulations.
Detailed description
Temporary mechanical circulatory support, including Extracorporeal Membrane Oxygenation (ECMO) and Impella, is increasingly used in refractory cardiogenic shock and severe cardiopulmonary failure. Despite major technological advancements and the constant refinements in critical care medicine, mortality in this group remains significant. While traditional hemodynamic and cardiac parameters are known risk factors, non-cardiac parameters such as acute metabolic destabilization, alterations in the hypothalamic-pituitary axis causing endocrine dysregulations (such as euthyroid sick syndrome) and nutritional deficiency play a critical role in the patients outcomes.
The primary objective is to identify independent predictors of mortality and clinical outcomes in patients requiring ECMO or Impella support, with particular focus on dynamic changes in metabolic status and thyroid hormone axes during critical illness. This is a prospective, single-center, consecutive observational cohort study conducted in a high-volume, tertiary cardiac intensive care center. Adult patients treated with ECMO or Impella will be enrolled upon consent. Upon enrollment the following data is to be colleted:
- Medical history (previous endocrine diseases, daily medications), pre-admission functional capacity, frailty, and nutritional history obtained via relative questionnaires.
- Serial blood gas analyses, coagulation profiles, standard metabolic panels, and detailed thyroid axis hormone levels (free T3, free T4, rT3, TSH) are obtained during routine clinical care.
- Daily echocardiography measurements and invasive hemodynamic monitoring.
- Mechanical ventilation modes and respiratory data, temporary mechanical circulatory support machine settings/parameters, continuous renal replacement therapy (CRRT) / hemoperfusion details, administered infusions, drugs and detailed enteral/parenteral nutrition tracking.
High-density data collection is conducted daily while the patient stays in the Cardiovascular Intensive Care Unit. If patient management is stepped down within the Institute, routine laboratory parameters continue to be tracked until hospital discharge. Hard primary endpoints focus on 30-day all-cause mortality and overall ICU mortality. Secondary endpoints involve cardiac and non-cardiac complication rates, nutritional impairment, and endocrine hormone changes. We use the routine treatment angorithms, the study is non-interventional.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult (>18 years) patients admitted to the Cardiovascular Intensive Care Unit of Gottsegen Gyorgy National Cardiovascular Institute receiving temporary mechanical circulatory support via ECMO and/or Impella.
Key inclusion criteria (3 listed)
- Adult patients (age ≥ 18 years)
- Treatment with ECMO and/or Impella support
- Informed consent provided by the patients next of kin/ legal representative
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU all-cause mortality
Time frame: From date of enrollment until the date of death from any cause or discharge from the Intensive Care Unit, whichever came first, assessed up to 1 year.
All-cause mortality during the Intensive Care Unit stay
28 day all-cause mortality
Time frame: From date of enrollment until the date of death from any cause, assessed up to 28 days.
All-cause mortality following initiation of ECMO or Impella support
4 secondary outcomes
Dynamic thyroid and metabolic alterations
Time frame: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year.
Cardiovascular and Non-Cardiovascular complications
Time frame: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
Nutritional and malnutritional intolarence
Time frame: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
All cause in-hospital mortality
Time frame: From date of enrollment until the date of death from any cause or discharge from hospital, whichever came first, assessed up to 1 year
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 21 Oct 2026.
- Background: PubMed 41588618Bear DE, Ridley EJ, Daly K, De Waele E, Al Dabbous T, Karpasiti T, Stoppe C, Barrett NA. 2025 ELSO Consensus Statement for the Provision and Management of Nutrition Therapy in Critically Ill Adult Patients Requiring Extracorporeal Membrane Oxygenation. ASAIO J. 2026 Feb 1;72(2):99-110. doi: 10.1097/MAT.0000000000002657. Epub 2026 Jan 22.
- Background: PubMed 39883803Ramsey S, Shehatta AL, Ramanathan K, Shekar K, Brodie D, Diaz R, Roberts A, Cruz S, Hodgson C, Zakhary B. Extracorporeal Life Support Organization 2024 Guideline for Early Rehabilitation or Mobilization of Adult Patients on Extracorporeal Membrane Oxygenation. ASAIO J. 2025 Mar 1;71(3):187-199. doi: 10.1097/MAT.0000000000002375. Epub 2025 Jan 30.
- Background: PubMed 39870417Hiser SL, Casey K, Nydahl P, Hodgson CL, Needham DM. Intensive care unit acquired weakness and physical rehabilitation in the ICU. BMJ. 2025 Jan 27;388:e077292. doi: 10.1136/bmj-2023-077292.
- Background: PubMed 36495215Dresen E, Naidoo O, Hill A, Elke G, Lindner M, Jonckheer J, De Waele E, Meybohm P, Modir R, Patel JJ, Christopher KB, Stoppe C. Medical nutrition therapy in patients receiving ECMO: Evidence-based guidance for clinical practice. JPEN J Parenter Enteral Nutr. 2023 Feb;47(2):220-235. doi: 10.1002/jpen.2467. Epub 2022 Dec 29.
- Background: PubMed 35348527Bridges BC, Dhar A, Ramanathan K, Steflik HJ, Schmidt M, Shekar K. Extracorporeal Life Support Organization Guidelines for Fluid Overload, Acute Kidney Injury, and Electrolyte Management. ASAIO J. 2022 May 1;68(5):611-618. doi: 10.1097/MAT.0000000000001702. Epub 2022 Mar 25.
- Background: PubMed 28448064Leeuwen L, van Heijst AFJ, van Rosmalen J, de Rijke YB, Beurskens LWJE, Tibboel D, van den Akker ELT, IJsselstijn H. Changes in thyroid hormone concentrations during neonatal extracorporeal membrane oxygenation. J Perinatol. 2017 Aug;37(8):906-910. doi: 10.1038/jp.2017.56. Epub 2017 Apr 27.
- Background: PubMed 30467031Holndonner-Kirst E, Nagy A, Czobor NR, Fazekas L, Dohan O, Kertai MD, Lex DJ, Sax B, Hartyanszky I, Merkely B, Gal J, Szekely A. The Impact of l-Thyroxine Treatment of Donors and Recipients on Postoperative Outcomes After Heart Transplantation. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1629-1635. doi: 10.1053/j.jvca.2018.10.024. Epub 2018 Oct 25.
- Background: PubMed 15642542Kozdag G, Ural D, Vural A, Agacdiken A, Kahraman G, Sahin T, Ural E, Komsuoglu B. Relation between free triiodothyronine/free thyroxine ratio, echocardiographic parameters and mortality in dilated cardiomyopathy. Eur J Heart Fail. 2005 Jan;7(1):113-8. doi: 10.1016/j.ejheart.2004.04.016.
- Background: PubMed 17315395Pingitore A, Iervasi G. Thyroid (dys)function in heart failure: is it a potential target for medical treatment? Vasc Health Risk Manag. 2005;1(2):97-100. doi: 10.2147/vhrm.1.2.97.64076. No abstract available.
- Background: PubMed 15694896Pingitore A, Landi P, Taddei MC, Ripoli A, L'Abbate A, Iervasi G. Triiodothyronine levels for risk stratification of patients with chronic heart failure. Am J Med. 2005 Feb;118(2):132-6. doi: 10.1016/j.amjmed.2004.07.052.
- Background: PubMed 8960429Opasich C, Pacini F, Ambrosino N, Riccardi PG, Febo O, Ferrari R, Cobelli F, Tavazzi L. Sick euthyroid syndrome in patients with moderate-to-severe chronic heart failure. Eur Heart J. 1996 Dec;17(12):1860-6. doi: 10.1093/oxfordjournals.eurheartj.a014804.
- Background: PubMed 12578873Iervasi G, Pingitore A, Landi P, Raciti M, Ripoli A, Scarlattini M, L'Abbate A, Donato L. Low-T3 syndrome: a strong prognostic predictor of death in patients with heart disease. Circulation. 2003 Feb 11;107(5):708-13. doi: 10.1161/01.cir.0000048124.64204.3f.
- Individual participant dataSharing planned: Undecided. Anonim data will be shared upon reasonable request.
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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 and Euthyroid Sick Syndrome, run by Gottsegen National Cardiovascular Institute at 1 site in Hungary.
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 3 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 21 Oct 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 Hungary. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU all-cause mortality (time frame: From date of enrollment until the date of death from any cause or discharge from the Intensive Care Unit, whichever came first, assessed up to 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 NCT07885618, which also lists 17 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 21 Oct 2026.