Atrial FibrillationAFLETES-MRINCT06424171
AFLETES-MRI: A Cardiac and Cerebral Magnetic Resonance Imaging Study in Athletes With Atrial Fibrillation
An observational study of Atrial Fibrillation and Stroke, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Participation in exercise improves cardiovascular health. However, long-term endurance exercise may increase the risk of an irregular heart rhythm called atrial fibrillation (AF). In AF, blood flow is altered, increasing the risk of clot formation in the heart which may enter the circulation and cause a stroke. Read more about this study
- Who is it for?
- Ages 40 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Cardiac and brain magnetic resonance imaging.
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Jan 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: - Male, competitive, veteran athletes and age/sex matched controls will be included.
Who may be able to join
- Male, atrial fibrillation.
- 40-64 years of age at the time of enrolment.
- Primarily (≥50% of competition) competes in an endurance type sport as defined by European Society of Cardiology 2020 guidelines.
- Competitive athlete*
- CHA2-DS2-VAsc =0/1 (excluding previous stroke).
- Competitive athlete defined by having trained ≥10 years, 6 hours per week as a self-reported average and having participated in at least one competitive event at regional level or above.
Who cannot join
- History of pre-existing cardiovascular disease
- Previous myocardial infarction, peripheral arterial disease
- Left ventricular systolic dysfunction (EF <45%)
- Heart muscle disease
- Complex congenital heart disease.
- Moderate or severe valvular disease.
Show all 10Show fewer
- Uncontrolled hypertension (180/100mmHg)
- Clotting or bleeding disorders, vasculitis
- Inherited cerebral disease
- Known to have an estimated glomerular filtration rate <30 ml/min/1.73m2.
Trial locations and contacts
1 site in 1 country.
Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc contact
United Kingdom1 site, 1 recruiting
- Recruiting
Department of Cardiovascular Sciences, University of Leicester
Leicester, Leicestershire, LE14AY
Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc, +447926082259, susil.pallikadavath@leicester.ac.uk
About this study
Official title: Atrial Fibrillation and the Risk of Stroke in Veteran athLETES: a Pilot Cardiac and Cerebral Magnetic Resonance Imaging Study - AFLETES-MRI
Participation in exercise improves cardiovascular health. However, long-term endurance exercise may increase the risk of an irregular heart rhythm called atrial fibrillation (AF).
In AF, blood flow is altered, increasing the risk of clot formation in the heart which may enter the circulation and cause a stroke. The risk of stroke can be reduced with the use of blood thinning medication. Athletes with atrial fibrillation, due to their healthy lifestyle, are generally felt to be at low risk of stroke and many would not be offered blood thinning treatment using risk scores used in clinical practice.
Read more
In a recent survey of almost one thousand athletes, the investigators found that there was an increased risk of stroke in those with atrial fibrillation, even in those without other risk factors for stroke.
To further investigate these findings, this study will use MRI scanning to look at the hearts and brains of athletes aged between 40-64 years old. The researchers will assess athletes with and without atrial fibrillation, as well as some athletes with atrial fibrillation who have had a stroke previously.
The MRI scans will measure heart size and function as well as blood flow patterns in the heart. The study will determine whether athletes with atrial fibrillation have evidence of stroke on brain MRI and whether these are related to abnormal flow patterns. The results will help us decide whether a larger study should be performed.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Cardiac and brain magnetic resonance imaging.
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac and brain magnetic resonance imaging.Diagnostic test
Cardiac magnetic resonance imaging with analysis using 4D flow. Brain magnetic resonance imaging to detect strokes, including microvascular strokes.
| Study group | Role | What they receive |
|---|---|---|
| Athletes with atrial fibrillation without diagnosed stroke. | Not described Receives: Diagnostic Test: Cardiac and brain magnetic resonance imaging. | |
| Athletes without atrial fibrillation. | Not described Receives: Diagnostic Test: Cardiac and brain magnetic resonance imaging. | |
| Athletes with atrial fibrillation and a diagnosed stroke. | Not described Receives: Diagnostic Test: Cardiac and brain magnetic resonance imaging. | |
| Healthy, non-athlete controls. | Not described Receives: Diagnostic Test: Cardiac and brain magnetic resonance imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke.
The number of participants with ischaemic white matter lesions, micro-infarcts and old infarcts.
Measured: Baseline.
Secondary outcomes (5)
Cardiac structure.
Left ventricular volume (ml).
Measured: Baseline.
Late gadolinium enhancement (LGE).
Presence of LGE. The number of participants with LGE will be compared between groups.
Measured: Baseline.
Left atrial flow-pathlines and streamlines.
Direction of pathlines and streamlines. The number of areas of stasis will be calculated for each group.
Measured: Baseline.
Cardiac function.
Ejection fraction of the left ventricular (%).
Measured: Baseline.
Left atrial stasis.
Number of areas of stasis in each group in the left atrium.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start22 Jan 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerry P McCann, MD, MRCP(UK), MB,ChB, Study chair, University of LeicesterSusil Pallikadavath, MRCP(UK), MBChB(hons), BSc, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06424171
- Sponsor's protocol ID
- 0917
- Acronym
- AFLETES-MRI
- Status last verified
- Jan 2024
- First submitted
- 26 Feb 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Newman W, Parry-Williams G, Wiles J, Edwards J, Hulbert S, Kipourou K, Papadakis M, Sharma R, O'Driscoll J. Risk of atrial fibrillation in athletes: a systematic review and meta-analysis. Br J Sports Med. 2021 Nov;55(21):1233-1238. doi: 10.1136/bjsports-2021-103994. Epub 2021 Jul 12.
PubMed 34253538Pallikadavath S, Richards C, Bountziouka V, Sandilands AJ, Graham-Brown MPM, Robinson T, Singh A, McCann GP. The AFLETES Study: Atrial Fibrillation in Veteran Athletes and the Risk of Stroke. Clin J Sport Med. 2023 May 1;33(3):209-216. doi: 10.1097/JSM.0000000000001115. Epub 2023 Apr 6.
PubMed 37042823Dyverfeldt P, Bissell M, Barker AJ, Bolger AF, Carlhall CJ, Ebbers T, Francios CJ, Frydrychowicz A, Geiger J, Giese D, Hope MD, Kilner PJ, Kozerke S, Myerson S, Neubauer S, Wieben O, Markl M. 4D flow cardiovascular magnetic resonance consensus statement. J Cardiovasc Magn Reson. 2015 Aug 10;17(1):72. doi: 10.1186/s12968-015-0174-5.
PubMed 26257141Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.
PubMed 31955707Xu Y, Zhao L, Zhang L, Han Y, Wang P, Yu S. Left Atrial Enlargement and the Risk of Stroke: A Meta-Analysis of Prospective Cohort Studies. Front Neurol. 2020 Feb 14;11:26. doi: 10.3389/fneur.2020.00026. eCollection 2020.
PubMed 32117002Androulakis E, Swoboda PP. The Role of Cardiovascular Magnetic Resonance in Sports Cardiology; Current Utility and Future Perspectives. Curr Treat Options Cardiovasc Med. 2018 Aug 31;20(10):86. doi: 10.1007/s11936-018-0679-y.
PubMed 30167977Graham-Brown MP, Gulsin GS, Parke K, Wormleighton J, Lai FY, Athithan L, Arnold JR, Burton JO, McCann GP, Singh AS. A comparison of the reproducibility of two cine-derived strain software programmes in disease states. Eur J Radiol. 2019 Apr;113:51-58. doi: 10.1016/j.ejrad.2019.01.026. Epub 2019 Jan 23.
PubMed 30927959D'Ascenzi F, Anselmi F, Focardi M, Mondillo S. Atrial Enlargement in the Athlete's Heart: Assessment of Atrial Function May Help Distinguish Adaptive from Pathologic Remodeling. J Am Soc Echocardiogr. 2018 Feb;31(2):148-157. doi: 10.1016/j.echo.2017.11.009. Epub 2017 Dec 13.
PubMed 29246514Androulakis E, Mouselimis D, Tsarouchas A, Antonopoulos A, Bakogiannis C, Papagkikas P, Vlachopoulos C. The Role of Cardiovascular Magnetic Resonance Imaging in the Assessment of Myocardial Fibrosis in Young and Veteran Athletes: Insights From a Meta-Analysis. Front Cardiovasc Med. 2021 Dec 21;8:784474. doi: 10.3389/fcvm.2021.784474. eCollection 2021.
PubMed 34993239Demirkiran A, van Ooij P, Westenberg JJM, Hofman MBM, van Assen HC, Schoonmade LJ, Asim U, Blanken CPS, Nederveen AJ, van Rossum AC, Gotte MJW. Clinical intra-cardiac 4D flow CMR: acquisition, analysis, and clinical applications. Eur Heart J Cardiovasc Imaging. 2022 Jan 24;23(2):154-165. doi: 10.1093/ehjci/jeab112.
PubMed 34143872Suwa K, Saitoh T, Takehara Y, Sano M, Nobuhara M, Saotome M, Urushida T, Katoh H, Satoh H, Sugiyama M, Wakayama T, Alley M, Sakahara H, Hayashi H. Characteristics of intra-left atrial flow dynamics and factors affecting formation of the vortex flow - analysis with phase-resolved 3-dimensional cine phase contrast magnetic resonance imaging. Circ J. 2015;79(1):144-52. doi: 10.1253/circj.CJ-14-0562. Epub 2014 Nov 13.
PubMed 25391258Fluckiger JU, Goldberger JJ, Lee DC, Ng J, Lee R, Goyal A, Markl M. Left atrial flow velocity distribution and flow coherence using four-dimensional FLOW MRI: a pilot study investigating the impact of age and Pre- and Postintervention atrial fibrillation on atrial hemodynamics. J Magn Reson Imaging. 2013 Sep;38(3):580-7. doi: 10.1002/jmri.23994. Epub 2013 Jan 4.
PubMed 23292793Lee DC, Markl M, Ng J, Carr M, Benefield B, Carr JC, Goldberger JJ. Three-dimensional left atrial blood flow characteristics in patients with atrial fibrillation assessed by 4D flow CMR. Eur Heart J Cardiovasc Imaging. 2016 Nov;17(11):1259-1268. doi: 10.1093/ehjci/jev304. Epub 2015 Nov 20.
PubMed 26590397Pelliccia A, Sharma S, Gati S, Back M, Borjesson M, Caselli S, Collet JP, Corrado D, Drezner JA, Halle M, Hansen D, Heidbuchel H, Myers J, Niebauer J, Papadakis M, Piepoli MF, Prescott E, Roos-Hesselink JW, Graham Stuart A, Taylor RS, Thompson PD, Tiberi M, Vanhees L, Wilhelm M; ESC Scientific Document Group. 2020 ESC Guidelines on sports cardiology and exercise in patients with cardiovascular disease. Eur Heart J. 2021 Jan 1;42(1):17-96. doi: 10.1093/eurheartj/ehaa605. No abstract available.
PubMed 32860412
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation and the Risk of Stroke in Veteran athLETES: a Pilot Cardiac and Cerebral Magnetic Resonance Imaging Study - AFLETES-MRI
- ClinicalTrials.gov ID
- NCT06424171
- Acronym / sponsor ID
- AFLETES-MRI / 0917
- Conditions
- Atrial Fibrillation, Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 May 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.
Participation in exercise improves cardiovascular health. However, long-term endurance exercise may increase the risk of an irregular heart rhythm called atrial fibrillation (AF).
In AF, blood flow is altered, increasing the risk of clot formation in the heart which may enter the circulation and cause a stroke. The risk of stroke can be reduced with the use of blood thinning medication. Athletes with atrial fibrillation, due to their healthy lifestyle, are generally felt to be at low risk of stroke and many would not be offered blood thinning treatment using risk scores used in clinical practice.
In a recent survey of almost one thousand athletes, the investigators found that there was an increased risk of stroke in those with atrial fibrillation, even in those without other risk factors for stroke.
To further investigate these findings, this study will use MRI scanning to look at the hearts and brains of athletes aged between 40-64 years old. The researchers will assess athletes with and without atrial fibrillation, as well as some athletes with atrial fibrillation who have had a stroke previously.
The MRI scans will measure heart size and function as well as blood flow patterns in the heart. The study will determine whether athletes with atrial fibrillation have evidence of stroke on brain MRI and whether these are related to abnormal flow patterns. The results will help us decide whether a larger study should be performed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Athletes with atrial fibrillation without diagnosed stroke. | – | Diagnostic Test: Cardiac and brain magnetic resonance imaging. |
| Athletes without atrial fibrillation. | – | Diagnostic Test: Cardiac and brain magnetic resonance imaging. |
| Athletes with atrial fibrillation and a diagnosed stroke. | – | Diagnostic Test: Cardiac and brain magnetic resonance imaging. |
| Healthy, non-athlete controls. | – | Diagnostic Test: Cardiac and brain magnetic resonance imaging. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- - Male, competitive, veteran athletes and age/sex matched controls will be included.
Key inclusion criteria (6 listed)
- Male, atrial fibrillation.
- 40-64 years of age at the time of enrolment.
- Primarily (≥50% of competition) competes in an endurance type sport as defined by European Society of Cardiology 2020 guidelines.
- Competitive athlete*
- CHA2-DS2-VAsc =0/1 (excluding previous stroke).
Key exclusion criteria (10 listed)
- History of pre-existing cardiovascular disease
- Previous myocardial infarction, peripheral arterial disease
- Left ventricular systolic dysfunction (EF <45%)
- Heart muscle disease
- Complex congenital heart disease.
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 and brain magnetic resonance imaging.Cardiac magnetic resonance imaging with analysis using 4D flow. Brain magnetic resonance imaging to detect strokes, including microvascular strokes. | Diagnostic test | Athletes with atrial fibrillation and a diagnosed stroke., Athletes with atrial fibrillation without diagnosed stroke., Athletes without atrial fibrillation., Healthy, non-athlete controls. |
Primary outcome
Stroke.
Time frame: Baseline.
The number of participants with ischaemic white matter lesions, micro-infarcts and old infarcts.
5 secondary outcomes
Cardiac structure.
Time frame: Baseline.
Late gadolinium enhancement (LGE).
Time frame: Baseline.
Left atrial flow-pathlines and streamlines.
Time frame: Baseline.
Cardiac function.
Time frame: Baseline.
Left atrial stasis.
Time frame: Baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Background: PubMed 34253538Newman W, Parry-Williams G, Wiles J, Edwards J, Hulbert S, Kipourou K, Papadakis M, Sharma R, O'Driscoll J. Risk of atrial fibrillation in athletes: a systematic review and meta-analysis. Br J Sports Med. 2021 Nov;55(21):1233-1238. doi: 10.1136/bjsports-2021-103994. Epub 2021 Jul 12.
- Background: PubMed 37042823Pallikadavath S, Richards C, Bountziouka V, Sandilands AJ, Graham-Brown MPM, Robinson T, Singh A, McCann GP. The AFLETES Study: Atrial Fibrillation in Veteran Athletes and the Risk of Stroke. Clin J Sport Med. 2023 May 1;33(3):209-216. doi: 10.1097/JSM.0000000000001115. Epub 2023 Apr 6.
- Background: PubMed 26257141Dyverfeldt P, Bissell M, Barker AJ, Bolger AF, Carlhall CJ, Ebbers T, Francios CJ, Frydrychowicz A, Geiger J, Giese D, Hope MD, Kilner PJ, Kozerke S, Myerson S, Neubauer S, Wieben O, Markl M. 4D flow cardiovascular magnetic resonance consensus statement. J Cardiovasc Magn Reson. 2015 Aug 10;17(1):72. doi: 10.1186/s12968-015-0174-5.
- Background: PubMed 31955707Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19.
- Background: PubMed 32117002Xu Y, Zhao L, Zhang L, Han Y, Wang P, Yu S. Left Atrial Enlargement and the Risk of Stroke: A Meta-Analysis of Prospective Cohort Studies. Front Neurol. 2020 Feb 14;11:26. doi: 10.3389/fneur.2020.00026. eCollection 2020.
- Background: PubMed 30167977Androulakis E, Swoboda PP. The Role of Cardiovascular Magnetic Resonance in Sports Cardiology; Current Utility and Future Perspectives. Curr Treat Options Cardiovasc Med. 2018 Aug 31;20(10):86. doi: 10.1007/s11936-018-0679-y.
- Background: PubMed 30927959Graham-Brown MP, Gulsin GS, Parke K, Wormleighton J, Lai FY, Athithan L, Arnold JR, Burton JO, McCann GP, Singh AS. A comparison of the reproducibility of two cine-derived strain software programmes in disease states. Eur J Radiol. 2019 Apr;113:51-58. doi: 10.1016/j.ejrad.2019.01.026. Epub 2019 Jan 23.
- Background: PubMed 29246514D'Ascenzi F, Anselmi F, Focardi M, Mondillo S. Atrial Enlargement in the Athlete's Heart: Assessment of Atrial Function May Help Distinguish Adaptive from Pathologic Remodeling. J Am Soc Echocardiogr. 2018 Feb;31(2):148-157. doi: 10.1016/j.echo.2017.11.009. Epub 2017 Dec 13.
- Background: PubMed 34993239Androulakis E, Mouselimis D, Tsarouchas A, Antonopoulos A, Bakogiannis C, Papagkikas P, Vlachopoulos C. The Role of Cardiovascular Magnetic Resonance Imaging in the Assessment of Myocardial Fibrosis in Young and Veteran Athletes: Insights From a Meta-Analysis. Front Cardiovasc Med. 2021 Dec 21;8:784474. doi: 10.3389/fcvm.2021.784474. eCollection 2021.
- Background: PubMed 34143872Demirkiran A, van Ooij P, Westenberg JJM, Hofman MBM, van Assen HC, Schoonmade LJ, Asim U, Blanken CPS, Nederveen AJ, van Rossum AC, Gotte MJW. Clinical intra-cardiac 4D flow CMR: acquisition, analysis, and clinical applications. Eur Heart J Cardiovasc Imaging. 2022 Jan 24;23(2):154-165. doi: 10.1093/ehjci/jeab112.
- Background: PubMed 25391258Suwa K, Saitoh T, Takehara Y, Sano M, Nobuhara M, Saotome M, Urushida T, Katoh H, Satoh H, Sugiyama M, Wakayama T, Alley M, Sakahara H, Hayashi H. Characteristics of intra-left atrial flow dynamics and factors affecting formation of the vortex flow - analysis with phase-resolved 3-dimensional cine phase contrast magnetic resonance imaging. Circ J. 2015;79(1):144-52. doi: 10.1253/circj.CJ-14-0562. Epub 2014 Nov 13.
- Background: PubMed 23292793Fluckiger JU, Goldberger JJ, Lee DC, Ng J, Lee R, Goyal A, Markl M. Left atrial flow velocity distribution and flow coherence using four-dimensional FLOW MRI: a pilot study investigating the impact of age and Pre- and Postintervention atrial fibrillation on atrial hemodynamics. J Magn Reson Imaging. 2013 Sep;38(3):580-7. doi: 10.1002/jmri.23994. Epub 2013 Jan 4.
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Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc contact
Gerry P McCann, MD, MRCP(UK), MB,ChB study chair
University of Leicester
Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc principal investigator
University of Leicester
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 Atrial Fibrillation and Stroke, run by University of Leicester at 1 site in United Kingdom.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 May 2024. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susil Pallikadavath, MRCP(UK), MBChB(hons), BSc (0116 252 2522, susil.pallikadavath@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke. (time frame: Baseline.). 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 NCT06424171, which also lists 14 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 22 May 2024.