Cardiogenic ShockECMO-FLOWNCT06936839
Optimal ECMO Flow in the Critical Phase of Cardiogenic Shock to Optimize Peripheral Organ Perfusion and Myocardial Stress
An observational study of Cardiogenic Shock, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Veno-arterial ECMO (VA ECMO) is considered the ultimate lifesaving technique in refractory cardiogenic shock (CS). However, VA ECMO is associated with potentially serious adverse effects and complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Obversation
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2025to 1 Apr 2026
- 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: Adult patients with cardiogenic shock treated with VA ECMO for less than 48 hours without any of the exclusion criteria.
Who may be able to join
- cardiogenic shock
- treated with VA ECMO for less than 48hours
Who cannot join
- ECMO initiated for refractory cardiac arrest
- Cardiac arres prior to the cardiogenic shock with Low-Flow > 30 min
- Noradrenaline dose > 1μg/kg/min, vasopressin dose > 2IU/h, dobutamine dose > 15μg/kg/min, adrenaline dose > 1μg/kg/min, or unstabilized vasopressors or inotropes
- Post-cardiotomy cardiogenic shock
- Septic shock
- Left ventricular unloading by Impella (CP/5) or atrioseptostomy
Show all 14Show fewer
- Atrial septal defect
- Ventricular septal defect
- Pregnant or breast-feeding women
- Patients protected by law (under guardianship or curatorship),
- Patient participating in another research study with an exclusion period still in progress
- Opposition to participation after having been informed
- Patient not affiliated to any health care system
- Patient unable to express non-opposition without available trusted person
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Montpellier University Hospital
Montpellier, Occitanie, 34090
Aurore Ughetto, MD, +33467335958, a-ughetto@chu-montpellier.fr
About this study
Veno-arterial ECMO (VA ECMO) is considered the ultimate lifesaving technique in refractory cardiogenic shock (CS). However, VA ECMO is associated with potentially serious adverse effects and complications. Many authors have demonstrated that VA ECMO increases left ventricular (LV) afterload, leading to increased LV stress, left ventricular end-diastolic pressure (LVEDP), and left atrial pressure (LAP). This pressure increase frequently results in pulmonary oedema and higher myocardial oxygen consumption. These complications are critical to patient survival and myocardial recovery and can lead to prolonged hospital stays and increased healthcare costs.
In the absence of clinical studies and strong recommendations, the optimized management of VA ECMO in clinical practice involves finding an ECMO flow that balances adequate organ perfusion with preserved ventricular ejection, while minimizing LV stress. Since the optimal flow changes with myocardial recovery, ramp tests are regularly performed to adjust ECMO flow.
Read more
To date, the optimized management of VA ECMO has been guided empirically. The aim of this study is to describe the consequences of variations in VA ECMO flow during the critical phase of cardiogenic shock on peripheral organ perfusion and LV stress. By analyzing the relationships between VA ECMO flow rate, peripheral perfusion, and myocardial stress, investigators aim to optimize flow settings-particularly by minimizing the potential complications of VA ECMO.
During the daily ramp tests, investigators plan to collect hemodynamic data (cardiac output, SvO₂, pulse pressure, EtCO₂, vasopressor and inotrope dosing), echocardiographic measurements, and organ perfusion indicators (NIRSS, CO₂ gap, respiratory quotient, lactate levels). Data will be collected on Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
- Conditions
- Cardiogenic Shock
- Being tested
- Obversation
- Keywords
- ECMO, optimal flow, cardiogenic shock, echocardiography, organ perfusion, myocardial recovery, human, adult, left ventricular overload
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObversationOther
Observing the optimal flow rate to reduce left ventricular stress and enhance peripheral organ perfusion during ramp tests (conducted at QECMO levels of 100%, 75%, 50%, and 25%, provided that SVO₂ remains >55% and NIRS rSO₂ remains >50%)
| Study group | Role | What they receive |
|---|---|---|
| study cohort | Adult patients at the early phase of a cardiogenic shock treated with veno-arterial ECMO (<48h) Receives: Other: Obversation |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimal flow
ECMO flow indexed to body surface area, defined as the flow with minimum PCWP (pulmonary capillary wedge pressure) and SvO2>55% at different times after ECMO start (Day 1, day 2 and day 3).
Measured: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
Secondary outcomes (5)
optimal flow according to echocardiography
ECMO flow indexed to body surface area, defined as the flow with minimum LVEDD (Left Ventricular End-Diastolic Diameter) and SvO2>55% at different times after ECMO start (Day 1, day 2 and day 3).
Measured: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
optimal flow according to the patient's native cardiac output
ECMO flow indexed to body surface area, defined as the flow with optimized native cardiac output (measured or estimated by EtCO2 and arterial pulse pressure) at different times after ECMO start (Day 1, day 2 and day 3).
Measured: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
optimal flow in subgroup 1 (low pulse pressure)
Optimal flow as defined by the primary outcome in patients with low arterial pulse pressure (<15mmHg) at different times after ECMO start (Day 1, day 2 and day 3).
Measured: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
optimal flow in subgroup 2 (normal pulse pressure)
Optimal flow as defined by the primary outcome in patients with normal arterial pulse pressure (>15mmHg) at different times after ECMO start (Day 1, day 2 and day 3).
Measured: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
Correlation between flow and other perfusion indicators
test the correlation between flow rate and tissue perfusion indicators (SvO2, NIRSS, Respiratory quotient, CO2 gap).
Measured: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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 University Hospital, MontpellierThe 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
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore Ughetto, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936839
- Sponsor's protocol ID
- RECHMPL24_0215
- Acronym
- ECMO-FLOW
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ostadal P, Mlcek M, Kruger A, Hala P, Lacko S, Mates M, Vondrakova D, Svoboda T, Hrachovina M, Janotka M, Psotova H, Strunina S, Kittnar O, Neuzil P. Increasing venoarterial extracorporeal membrane oxygenation flow negatively affects left ventricular performance in a porcine model of cardiogenic shock. J Transl Med. 2015 Aug 15;13:266. doi: 10.1186/s12967-015-0634-6.
PubMed 26275717Burkhoff D, Sayer G, Doshi D, Uriel N. Hemodynamics of Mechanical Circulatory Support. J Am Coll Cardiol. 2015 Dec 15;66(23):2663-2674. doi: 10.1016/j.jacc.2015.10.017.
PubMed 26670067Fuhrman BP, Hernan LJ, Rotta AT, Heard CM, Rosenkranz ER. Pathophysiology of cardiac extracorporeal membrane oxygenation. Artif Organs. 1999 Nov;23(11):966-9. doi: 10.1046/j.1525-1594.1999.06484.x.
PubMed 10564298Burkhoff D, Sagawa K. Ventricular efficiency predicted by an analytical model. Am J Physiol. 1986 Jun;250(6 Pt 2):R1021-7. doi: 10.1152/ajpregu.1986.250.6.R1021.
PubMed 3717375Mallat J, Pepy F, Lemyze M, Gasan G, Vangrunderbeeck N, Tronchon L, Vallet B, Thevenin D. Central venous-to-arterial carbon dioxide partial pressure difference in early resuscitation from septic shock: a prospective observational study. Eur J Anaesthesiol. 2014 Jul;31(7):371-80. doi: 10.1097/EJA.0000000000000064.
PubMed 24625464Mesquida J, Saludes P, Gruartmoner G, Espinal C, Torrents E, Baigorri F, Artigas A. Central venous-to-arterial carbon dioxide difference combined with arterial-to-venous oxygen content difference is associated with lactate evolution in the hemodynamic resuscitation process in early septic shock. Crit Care. 2015 Mar 28;19(1):126. doi: 10.1186/s13054-015-0858-0.
PubMed 25888382Routsi C, Vincent JL, Bakker J, De Backer D, Lejeune P, d'Hollander A, Le Clerc JL, Kahn RJ. Relation between oxygen consumption and oxygen delivery in patients after cardiac surgery. Anesth Analg. 1993 Dec;77(6):1104-10. doi: 10.1213/00000539-199312000-00004.
PubMed 8250298Vallet B, Teboul JL, Cain S, Curtis S. Venoarterial CO(2) difference during regional ischemic or hypoxic hypoxia. J Appl Physiol (1985). 2000 Oct;89(4):1317-21. doi: 10.1152/jappl.2000.89.4.1317.
PubMed 11007564Bakker J, Vincent JL, Gris P, Leon M, Coffernils M, Kahn RJ. Veno-arterial carbon dioxide gradient in human septic shock. Chest. 1992 Feb;101(2):509-15. doi: 10.1378/chest.101.2.509.
PubMed 1735281Mecher CE, Rackow EC, Astiz ME, Weil MH. Venous hypercarbia associated with severe sepsis and systemic hypoperfusion. Crit Care Med. 1990 Jun;18(6):585-9. doi: 10.1097/00003246-199006000-00001.
PubMed 2111753Groeneveld AB. Interpreting the venous-arterial PCO2 difference. Crit Care Med. 1998 Jun;26(6):979-80. doi: 10.1097/00003246-199806000-00002. No abstract available.
PubMed 9635634Faden H. Prophylactic antibiotics in pediatrics cardiovascular surgery: current practices. Ann Thorac Surg. 1981 Mar;31(3):211-3. doi: 10.1016/s0003-4975(10)60928-9.
PubMed 7212816Moller JE, Sionis A, Aissaoui N, Ariza A, Belohlavek J, De Backer D, Farber G, Gollmann-Tepekoylu C, Mebazaa A, Price S, Swol J, Thiele H, Hassager C. Step by step daily management of short-term mechanical circulatory support for cardiogenic shock in adults in the intensive cardiac care unit: a clinical consensus statement of the Association for Acute CardioVascular Care of the European Society of Cardiology SC, the European Society of Intensive Care Medicine, the European branch of the Extracorporeal Life Support Organization, and the European Association for Cardio-Thoracic Surgery. Eur Heart J Acute Cardiovasc Care. 2023 Jul 7;12(7):475-485. doi: 10.1093/ehjacc/zuad064.
PubMed 37315190Chiolero RL, Revelly JP, Leverve X, Gersbach P, Cayeux MC, Berger MM, Tappy L. Effects of cardiogenic shock on lactate and glucose metabolism after heart surgery. Crit Care Med. 2000 Dec;28(12):3784-91. doi: 10.1097/00003246-200012000-00002.
PubMed 11153615Khosravani H, Shahpori R, Stelfox HT, Kirkpatrick AW, Laupland KB. Occurrence and adverse effect on outcome of hyperlactatemia in the critically ill. Crit Care. 2009;13(3):R90. doi: 10.1186/cc7918. Epub 2009 Jun 12.
PubMed 19523194
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal ECMO Flow in the Critical Phase of Cardiogenic Shock to Optimize Peripheral Organ Perfusion and Myocardial Stress
- ClinicalTrials.gov ID
- NCT06936839
- Acronym / sponsor ID
- ECMO-FLOW / RECHMPL24_0215
- Conditions
- Cardiogenic Shock
- Keywords
- ECMO, optimal flow, cardiogenic shock, echocardiography, organ perfusion, myocardial recovery, human, adult
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 20 Apr 2025 (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.
Veno-arterial ECMO (VA ECMO) is considered the ultimate lifesaving technique in refractory cardiogenic shock (CS). However, VA ECMO is associated with potentially serious adverse effects and complications. Many authors have demonstrated that VA ECMO increases left ventricular (LV) afterload, leading to increased LV stress, left ventricular end-diastolic pressure (LVEDP), and left atrial pressure (LAP). This pressure increase frequently results in pulmonary oedema and higher myocardial oxygen consumption. These complications are critical to patient survival and myocardial recovery and can lead to prolonged hospital stays and increased healthcare costs.
In the absence of clinical studies and strong recommendations, the optimized management of VA ECMO in clinical practice involves finding an ECMO flow that balances adequate organ perfusion with preserved ventricular ejection, while minimizing LV stress. Since the optimal flow changes with myocardial recovery, ramp tests are regularly performed to adjust ECMO flow.
To date, the optimized management of VA ECMO has been guided empirically. The aim of this study is to describe the consequences of variations in VA ECMO flow during the critical phase of cardiogenic shock on peripheral organ perfusion and LV stress. By analyzing the relationships between VA ECMO flow rate, peripheral perfusion, and myocardial stress, investigators aim to optimize flow settings-particularly by minimizing the potential complications of VA ECMO.
During the daily ramp tests, investigators plan to collect hemodynamic data (cardiac output, SvO₂, pulse pressure, EtCO₂, vasopressor and inotrope dosing), echocardiographic measurements, and organ perfusion indicators (NIRSS, CO₂ gap, respiratory quotient, lactate levels). Data will be collected on Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study cohort | – | Other: ObversationAdult patients at the early phase of a cardiogenic shock treated with veno-arterial ECMO (<48h) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cardiogenic shock treated with VA ECMO for less than 48 hours without any of the exclusion criteria.
Key inclusion criteria (2 listed)
- cardiogenic shock
- treated with VA ECMO for less than 48hours
Key exclusion criteria (14 listed)
- ECMO initiated for refractory cardiac arrest
- Cardiac arres prior to the cardiogenic shock with Low-Flow > 30 min
- Noradrenaline dose > 1μg/kg/min, vasopressin dose > 2IU/h, dobutamine dose > 15μg/kg/min, adrenaline dose > 1μg/kg/min, or unstabilized vasopressors or inotropes
- Post-cardiotomy cardiogenic shock
- Septic shock
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 |
|---|---|---|
| ObversationObserving the optimal flow rate to reduce left ventricular stress and enhance peripheral organ perfusion during ramp tests (conducted at QECMO levels of 100%, 75%, 50%, and 25%, provided that SVO₂ remains >55% and NIRS rSO₂ remains >50%) | Other | study cohort |
Primary outcome
optimal flow
Time frame: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
ECMO flow indexed to body surface area, defined as the flow with minimum PCWP (pulmonary capillary wedge pressure) and SvO2>55% at different times after ECMO start (Day 1, day 2 and day 3).
5 secondary outcomes
optimal flow according to echocardiography
Time frame: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
optimal flow according to the patient's native cardiac output
Time frame: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
optimal flow in subgroup 1 (low pulse pressure)
Time frame: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
optimal flow in subgroup 2 (normal pulse pressure)
Time frame: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
Correlation between flow and other perfusion indicators
Time frame: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).
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 20 Apr 2025.
- Background: PubMed 26275717Ostadal P, Mlcek M, Kruger A, Hala P, Lacko S, Mates M, Vondrakova D, Svoboda T, Hrachovina M, Janotka M, Psotova H, Strunina S, Kittnar O, Neuzil P. Increasing venoarterial extracorporeal membrane oxygenation flow negatively affects left ventricular performance in a porcine model of cardiogenic shock. J Transl Med. 2015 Aug 15;13:266. doi: 10.1186/s12967-015-0634-6.
- Background: PubMed 26670067Burkhoff D, Sayer G, Doshi D, Uriel N. Hemodynamics of Mechanical Circulatory Support. J Am Coll Cardiol. 2015 Dec 15;66(23):2663-2674. doi: 10.1016/j.jacc.2015.10.017.
- Background: PubMed 10564298Fuhrman BP, Hernan LJ, Rotta AT, Heard CM, Rosenkranz ER. Pathophysiology of cardiac extracorporeal membrane oxygenation. Artif Organs. 1999 Nov;23(11):966-9. doi: 10.1046/j.1525-1594.1999.06484.x.
- Background: PubMed 3717375Burkhoff D, Sagawa K. Ventricular efficiency predicted by an analytical model. Am J Physiol. 1986 Jun;250(6 Pt 2):R1021-7. doi: 10.1152/ajpregu.1986.250.6.R1021.
- Background: PubMed 24625464Mallat J, Pepy F, Lemyze M, Gasan G, Vangrunderbeeck N, Tronchon L, Vallet B, Thevenin D. Central venous-to-arterial carbon dioxide partial pressure difference in early resuscitation from septic shock: a prospective observational study. Eur J Anaesthesiol. 2014 Jul;31(7):371-80. doi: 10.1097/EJA.0000000000000064.
- Background: PubMed 25888382Mesquida J, Saludes P, Gruartmoner G, Espinal C, Torrents E, Baigorri F, Artigas A. Central venous-to-arterial carbon dioxide difference combined with arterial-to-venous oxygen content difference is associated with lactate evolution in the hemodynamic resuscitation process in early septic shock. Crit Care. 2015 Mar 28;19(1):126. doi: 10.1186/s13054-015-0858-0.
- Background: PubMed 8250298Routsi C, Vincent JL, Bakker J, De Backer D, Lejeune P, d'Hollander A, Le Clerc JL, Kahn RJ. Relation between oxygen consumption and oxygen delivery in patients after cardiac surgery. Anesth Analg. 1993 Dec;77(6):1104-10. doi: 10.1213/00000539-199312000-00004.
- Background: PubMed 11007564Vallet B, Teboul JL, Cain S, Curtis S. Venoarterial CO(2) difference during regional ischemic or hypoxic hypoxia. J Appl Physiol (1985). 2000 Oct;89(4):1317-21. doi: 10.1152/jappl.2000.89.4.1317.
- Background: PubMed 1735281Bakker J, Vincent JL, Gris P, Leon M, Coffernils M, Kahn RJ. Veno-arterial carbon dioxide gradient in human septic shock. Chest. 1992 Feb;101(2):509-15. doi: 10.1378/chest.101.2.509.
- Background: PubMed 2111753Mecher CE, Rackow EC, Astiz ME, Weil MH. Venous hypercarbia associated with severe sepsis and systemic hypoperfusion. Crit Care Med. 1990 Jun;18(6):585-9. doi: 10.1097/00003246-199006000-00001.
- Background: PubMed 9635634Groeneveld AB. Interpreting the venous-arterial PCO2 difference. Crit Care Med. 1998 Jun;26(6):979-80. doi: 10.1097/00003246-199806000-00002. No abstract available.
- Background: PubMed 7212816Faden H. Prophylactic antibiotics in pediatrics cardiovascular surgery: current practices. Ann Thorac Surg. 1981 Mar;31(3):211-3. doi: 10.1016/s0003-4975(10)60928-9.
- Individual participant dataSharing planned: No
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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.
Aurore Ughetto, MD principal investigator
University Hospital, Montpellier
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 University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 14 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: opening soon, as of the sponsor's last update on 20 Apr 2025. 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 France. 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 Aurore Ughetto, MD (+33467335958, a-ughetto@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optimal flow (time frame: Day 1 (ECMO initiation), Day 2 (24 hours after ECMO initiation), and Day 3 (48 hours after ECMO initiation).). 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 NCT06936839, which also lists 18 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 20 Apr 2025.