MyocarditisPROGNOSTICNCT05949450
Prognostic Role of High Sensitivity Troponin During Follow up in the Evolution of Acute Myocarditis
An observational study of Myocarditis, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The goal of this observational study is to observe if ultra-sensitive troponins (us) measurement between 3 and 6 months after the acute event will be sensitive enough to dispense with all other examinations, particularly cardiac magnetic resonance imaging (MRI), in patients suffering from myocarditis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocarditis
- How many people
- 244 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2023to Jul 2030
- 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: Any patient hospitalized for myocarditis at Grenoble Alpes University Hospital (CHUGA) or at Lyon University Hospital, with standardized reassessment at 3-6 months.
Who may be able to join
- Male or female patients over 18 years of age
- Patients hospitalized at Grenoble Alpes University Hospital and Lyon University Hospital between June 2016 and June 2025
- Having presented chest pain and ≥1 diagnostic criteria or if no chest pain, presence of ≥2 diagnostic criteria below :
- Electrical abnormalities (supra- or sub-ST, T-wave inversion, atrioventricular blocks 1-3 conduction disorders)
- Elevation of cardiac biomarkers (troponin)
- Kinetic abnormalities on cardiac ultrasound
Show all 9Show fewer
- Associated with ≥2 MRI criteria of tissue abnormality (edema, hyperhemia, myocardial fibrosis)
- Patient affiliated to a social security scheme or beneficiary of such a scheme
- No opposition to participation
Who cannot join
- Absence of documented coronary artery disease (cardiac CT or coronary angiography) or age <30 and low risk of coronary artery disease.
- Myocarditis secondary to immunotherapy.
- Presence of documented coronary artery disease (coronary angiography or cardiac CT)
- Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy)
- Infiltrative heart disease (sarcoidosis or cardiac amyloidosis)
- Severe valve disease
Show all 14Show fewer
- Takotsubo
- Constrictive or chronic pericarditis
- Loeffler's endocarditis
- Non-compaction of the left ventricle
- Cardiac tumor
- Pulmonary embolism
- Coronary spasm
- Patients covered by articles L1121-5 to L1121-8 of the French Public Health Code (pregnant women, parturients, nursing mothers; persons deprived of liberty by judicial or administrative decision; protected adults)
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
Grenoble University Hospital
La Tronche, 38700
Clémence Charlon, 0476766652, ccharlon@chu-grenoble.fr
About this study
Official title: Prognostic Role of Troponin Dosed at 3 to 6 Months in the Evolution of Acute Myocarditis
The goal of this observational study is to observe if ultra-sensitive troponins (us) measurement between 3 and 6 months after the acute event will be sensitive enough to dispense with all other examinations, particularly cardiac magnetic resonance imaging (MRI), in patients suffering from myocarditis.
The investigators will collect patient events by telephone, once a year for 4 years.
Read the detailed description
Myocarditis is a frequent pathology with a heterogeneous initial clinical presentation. The long-term course of the disease is variable, with the possibility of healing and recovery, but also the likelihood of long-term deterioration, with the development of true dilated cardiomyopathy. While diagnostic criteria in the initial phase are well codified, notably with cardiac MRI, follow-up methods are less standardized. Re-evaluation between 3 and 6 months is not carried out by all teams, and if it is, the examinations performed vary from one team to another. Grenoble team has demonstrated the prognostic role of MRI reassessment at 3 and 6 months. It is also common to measure troponins to detect chronic myocarditis. However, this assay has evolved over time with the advent of ultra-sensitive troponins (us). These appear to be much more sensitive, and this increased sensitivity may lead to a change in care strategies.
For example, in the management of chest pain in emergency departments before the era of us troponins, the use of coronary CT scans improved patient management. This benefit of imaging has disappeared since the advent of troponin us.
The hypothesis of investigators is that troponin us measurement between 3 and 6 months after the acute event will be sensitive enough to dispense with all other examinations, particularly cardiac MRI, in order to identify patients at risk of poor prognosis.
- Conditions
- Myocarditis
- Keywords
- myocarditis, troponine us
- Medical subject headings
- Myocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE) rate at 4 years
MACE being defined by a composite criterion: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) cardiac transplantation,4) documented sustained ventricular arrhythmias >30s, 5) recurrence of myocarditis.
Measured: 4 years
Secondary outcomes (10)
Troponin us measured at 3 to 6 months
Prognostic value of troponin and MACE apparition. Troponin assays will be reported in ng/l.
MACE being defined by a composite criterion: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) cardiac transplantation,4) documented sustained ventricular arrhythmias >30s, 5) recurrence of myocarditis. The MACE rate will be counted to answer the objective.
Measured: 3 to 6 months
MACE apparition rate
Prognostic value of troponin and MACE apparition. Troponin assays will be reported in ng/l.
MACE being defined by a composite criterion: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) cardiac transplantation,4) documented sustained ventricular arrhythmias >30s, 5) recurrence of myocarditis. The MACE rate will be counted to answer the objective.
Measured: 3 to 6 months
Troponin us measured at 3 to 6 months
Prognostic value of Troponin us measured (in ng/l) at 3 to 6 months and watts generated on stress test at 3 to 6 months.
Measured: 3 to 6 months
watts generated on stress test at 3 to 6 months
Prognostic value of Troponin us measured (in ng/l) at 3 to 6 months and watts generated on stress test at 3 to 6 months.
Results of the stress test will be reported in watts.
Measured: 3 to 6 months
Troponin Us measured at 3 to 6 months
Prognostic value of Troponin Us (ng/l) measured at 3 to 6 months and presence of abnormality on frequency holter Presence of abnormality on frequency holter is defined by the transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia.
Measured: 3 to 6 months
Presence of abnormality on frequency holter (transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia).
Prognostic value of Troponin Us (ng/l) measured at 3 to 6 months and presence of abnormality on frequency holter Presence of abnormality on frequency holter is defined by the transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia.
Presence of abnormality on frequency holter is defined by the transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia.
Measured: 3 to 6 months
cardiac MRI.
Relationship between Troponin Us measured at 3 and 6 months and cardiac ultrasound measurements and cardiac MRI.
Cardiac ultrasound measurements (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking) Data collected during cardiac MRI are right and left ventricular function in percentage, cardiac mass in gram, and percentage of left ventricular fibrosis).
Measured: 3 to 6 months
Troponin Us measured at 3 and 6 months
Relationship between Troponin Us measured at 3 and 6 months and cardiac ultrasound measurements and cardiac MRI.
Cardiac ultrasound measurements (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking) Data collected during cardiac MRI are right and left ventricular function in percentage, cardiac mass in gram, and percentage of left ventricular fibrosis).
Measured: 3 to 6 months
cardiac ultrasound measurements
Relationship between Troponin Us measured at 3 and 6 months and cardiac ultrasound measurements and cardiac MRI.
Cardiac ultrasound measurements (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking) Data collected during cardiac MRI are right and left ventricular function in percentage, cardiac mass in gram, and percentage of left ventricular fibrosis).
Measured: 3 to 6 months
The rate of occurrence of the following events at 30 days: ventricular arrhythmias, heart failure, need for heart transplantation, need for circulatory support, recovered cardiorespiratory arrest, all-cause mortality
Relationship between Troponin Us measured at 3 and 6 months and cardiac ultrasound measurements and cardiac MRI.
Cardiac ultrasound measurements (longitudinal, radial and circumferential strain of the left ventricle in speckle tracking, left atrial strain in speckle tracking) Data collected during cardiac MRI are right and left ventricular function in percentage, cardiac mass in gram, and percentage of left ventricular fibrosis).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study startJul 2023 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949450
- Sponsor's protocol ID
- 38RC23.0091
- Other IDs
- 2023-A0078-37
- Acronym
- PROGNOSTIC
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ammirati E, Frigerio M, Adler ED, Basso C, Birnie DH, Brambatti M, Friedrich MG, Klingel K, Lehtonen J, Moslehi JJ, Pedrotti P, Rimoldi OE, Schultheiss HP, Tschope C, Cooper LT Jr, Camici PG. Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document. Circ Heart Fail. 2020 Nov;13(11):e007405. doi: 10.1161/CIRCHEARTFAILURE.120.007405. Epub 2020 Nov 12.
PubMed 33176455Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.
PubMed 23824828Barone-Rochette G, Augier C, Rodiere M, Quesada JL, Foote A, Bouvaist H, Marliere S, Fagret D, Baguet JP, Vanzetto G. Potentially simple score of late gadolinium enhancement cardiac MR in acute myocarditis outcome. J Magn Reson Imaging. 2014 Dec;40(6):1347-54. doi: 10.1002/jmri.24504. Epub 2013 Dec 1.
PubMed 24293405Dedic A, Lubbers MM, Schaap J, Lammers J, Lamfers EJ, Rensing BJ, Braam RL, Nathoe HM, Post JC, Nielen T, Beelen D, le Cocq d'Armandville MC, Rood PP, Schultz CJ, Moelker A, Ouhlous M, Boersma E, Nieman K. Coronary CT Angiography for Suspected ACS in the Era of High-Sensitivity Troponins: Randomized Multicenter Study. J Am Coll Cardiol. 2016 Jan 5;67(1):16-26. doi: 10.1016/j.jacc.2015.10.045.
PubMed 26764061Aquaro GD, Perfetti M, Camastra G, Monti L, Dellegrottaglie S, Moro C, Pepe A, Todiere G, Lanzillo C, Scatteia A, Di Roma M, Pontone G, Perazzolo Marra M, Barison A, Di Bella G; Cardiac Magnetic Resonance Working Group of the Italian Society of Cardiology. Cardiac MR With Late Gadolinium Enhancement in Acute Myocarditis With Preserved Systolic Function: ITAMY Study. J Am Coll Cardiol. 2017 Oct 17;70(16):1977-1987. doi: 10.1016/j.jacc.2017.08.044.
PubMed 29025554Grani C, Eichhorn C, Biere L, Murthy VL, Agarwal V, Kaneko K, Cuddy S, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Prognostic Value of Cardiac Magnetic Resonance Tissue Characterization in Risk Stratifying Patients With Suspected Myocarditis. J Am Coll Cardiol. 2017 Oct 17;70(16):1964-1976. doi: 10.1016/j.jacc.2017.08.050.
PubMed 29025553Wong BTW, Christiansen JP. Clinical Characteristics and Prognostic Factors of Myocarditis in New Zealand Patients. Heart Lung Circ. 2020 Aug;29(8):1139-1145. doi: 10.1016/j.hlc.2020.01.007. Epub 2020 Feb 17.
PubMed 32094080
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Troponin Dosed at 3 to 6 Months in the Evolution of Acute Myocarditis
- ClinicalTrials.gov ID
- NCT05949450
- Acronym / sponsor ID
- PROGNOSTIC / 38RC23.0091
- Conditions
- Myocarditis
- Keywords
- myocarditis, troponine us
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 18 Jul 2023 (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.
The goal of this observational study is to observe if ultra-sensitive troponins (us) measurement between 3 and 6 months after the acute event will be sensitive enough to dispense with all other examinations, particularly cardiac magnetic resonance imaging (MRI), in patients suffering from myocarditis.
The investigators will collect patient events by telephone, once a year for 4 years.
Detailed description
Myocarditis is a frequent pathology with a heterogeneous initial clinical presentation. The long-term course of the disease is variable, with the possibility of healing and recovery, but also the likelihood of long-term deterioration, with the development of true dilated cardiomyopathy. While diagnostic criteria in the initial phase are well codified, notably with cardiac MRI, follow-up methods are less standardized. Re-evaluation between 3 and 6 months is not carried out by all teams, and if it is, the examinations performed vary from one team to another. Grenoble team has demonstrated the prognostic role of MRI reassessment at 3 and 6 months. It is also common to measure troponins to detect chronic myocarditis. However, this assay has evolved over time with the advent of ultra-sensitive troponins (us). These appear to be much more sensitive, and this increased sensitivity may lead to a change in care strategies.
For example, in the management of chest pain in emergency departments before the era of us troponins, the use of coronary CT scans improved patient management. This benefit of imaging has disappeared since the advent of troponin us.
The hypothesis of investigators is that troponin us measurement between 3 and 6 months after the acute event will be sensitive enough to dispense with all other examinations, particularly cardiac MRI, in order to identify patients at risk of poor prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient hospitalized for myocarditis at Grenoble Alpes University Hospital (CHUGA) or at Lyon University Hospital, with standardized reassessment at 3-6 months.
Key inclusion criteria (9 listed)
- Male or female patients over 18 years of age
- Patients hospitalized at Grenoble Alpes University Hospital and Lyon University Hospital between June 2016 and June 2025
- Having presented chest pain and ≥1 diagnostic criteria or if no chest pain, presence of ≥2 diagnostic criteria below :
- Associated with ≥2 MRI criteria of tissue abnormality (edema, hyperhemia, myocardial fibrosis)
- Patient affiliated to a social security scheme or beneficiary of such a scheme
Key exclusion criteria (14 listed)
- Absence of documented coronary artery disease (cardiac CT or coronary angiography) or age <30 and low risk of coronary artery disease.
- Myocarditis secondary to immunotherapy.
- Presence of documented coronary artery disease (coronary angiography or cardiac CT)
- Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy)
- Infiltrative heart disease (sarcoidosis or cardiac amyloidosis)
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
Major Adverse Cardiac Events (MACE) rate at 4 years
Time frame: 4 years
MACE being defined by a composite criterion: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) cardiac transplantation,4) documented sustained ventricular arrhythmias >30s, 5) recurrence of myocarditis.
10 secondary outcomes
Troponin us measured at 3 to 6 months
Time frame: 3 to 6 months
MACE apparition rate
Time frame: 3 to 6 months
Troponin us measured at 3 to 6 months
Time frame: 3 to 6 months
watts generated on stress test at 3 to 6 months
Time frame: 3 to 6 months
Troponin Us measured at 3 to 6 months
Time frame: 3 to 6 months
Presence of abnormality on frequency holter (transition to atrial fibrillation and/or unsustained or sustained ventricular tachycardia).
Time frame: 3 to 6 months
cardiac MRI.
Time frame: 3 to 6 months
Troponin Us measured at 3 and 6 months
Time frame: 3 to 6 months
cardiac ultrasound measurements
Time frame: 3 to 6 months
The rate of occurrence of the following events at 30 days: ventricular arrhythmias, heart failure, need for heart transplantation, need for circulatory support, recovered cardiorespiratory arrest, all-cause mortality
Time frame: 30 days
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 18 Jul 2023.
- Background: PubMed 33176455Ammirati E, Frigerio M, Adler ED, Basso C, Birnie DH, Brambatti M, Friedrich MG, Klingel K, Lehtonen J, Moslehi JJ, Pedrotti P, Rimoldi OE, Schultheiss HP, Tschope C, Cooper LT Jr, Camici PG. Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document. Circ Heart Fail. 2020 Nov;13(11):e007405. doi: 10.1161/CIRCHEARTFAILURE.120.007405. Epub 2020 Nov 12.
- Background: PubMed 23824828Caforio AL, Pankuweit S, Arbustini E, Basso C, Gimeno-Blanes J, Felix SB, Fu M, Helio T, Heymans S, Jahns R, Klingel K, Linhart A, Maisch B, McKenna W, Mogensen J, Pinto YM, Ristic A, Schultheiss HP, Seggewiss H, Tavazzi L, Thiene G, Yilmaz A, Charron P, Elliott PM; European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: a position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2013 Sep;34(33):2636-48, 2648a-2648d. doi: 10.1093/eurheartj/eht210. Epub 2013 Jul 3.
- Background: PubMed 24293405Barone-Rochette G, Augier C, Rodiere M, Quesada JL, Foote A, Bouvaist H, Marliere S, Fagret D, Baguet JP, Vanzetto G. Potentially simple score of late gadolinium enhancement cardiac MR in acute myocarditis outcome. J Magn Reson Imaging. 2014 Dec;40(6):1347-54. doi: 10.1002/jmri.24504. Epub 2013 Dec 1.
- Background: PubMed 26764061Dedic A, Lubbers MM, Schaap J, Lammers J, Lamfers EJ, Rensing BJ, Braam RL, Nathoe HM, Post JC, Nielen T, Beelen D, le Cocq d'Armandville MC, Rood PP, Schultz CJ, Moelker A, Ouhlous M, Boersma E, Nieman K. Coronary CT Angiography for Suspected ACS in the Era of High-Sensitivity Troponins: Randomized Multicenter Study. J Am Coll Cardiol. 2016 Jan 5;67(1):16-26. doi: 10.1016/j.jacc.2015.10.045.
- Background: PubMed 29025554Aquaro GD, Perfetti M, Camastra G, Monti L, Dellegrottaglie S, Moro C, Pepe A, Todiere G, Lanzillo C, Scatteia A, Di Roma M, Pontone G, Perazzolo Marra M, Barison A, Di Bella G; Cardiac Magnetic Resonance Working Group of the Italian Society of Cardiology. Cardiac MR With Late Gadolinium Enhancement in Acute Myocarditis With Preserved Systolic Function: ITAMY Study. J Am Coll Cardiol. 2017 Oct 17;70(16):1977-1987. doi: 10.1016/j.jacc.2017.08.044.
- Background: PubMed 29025553Grani C, Eichhorn C, Biere L, Murthy VL, Agarwal V, Kaneko K, Cuddy S, Aghayev A, Steigner M, Blankstein R, Jerosch-Herold M, Kwong RY. Prognostic Value of Cardiac Magnetic Resonance Tissue Characterization in Risk Stratifying Patients With Suspected Myocarditis. J Am Coll Cardiol. 2017 Oct 17;70(16):1964-1976. doi: 10.1016/j.jacc.2017.08.050.
- Background: PubMed 32094080Wong BTW, Christiansen JP. Clinical Characteristics and Prognostic Factors of Myocarditis in New Zealand Patients. Heart Lung Circ. 2020 Aug;29(8):1139-1145. doi: 10.1016/j.hlc.2020.01.007. Epub 2020 Feb 17.
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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 Myocarditis, run by University Hospital, Grenoble 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 9 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 18 Jul 2023. 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 Gilles Barone-Rochette, MD, PhD (0476768888, gbarone@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) rate at 4 years (time frame: 4 years). 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 NCT05949450, which also lists 7 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 18 Jul 2023.