Heart ArrestTdBTSNCT03310450

Tour de Borobudur Troponin Study on Predictors and Synergistic Role of MDA and Hs-CRP Levels

An observational study of Heart Arrest and Sport Injury, run by Universitas Negeri Semarang at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Prospective observational study to determine predictors that related to cardiac troponin I (cTnI) release, malondialdehyde (MDA) and high sensitivity C Reactive Protein (hs-CRP) after Tour de Borobudur (TdB) 2017 Read more about this study

Who is it for?: Ages 25 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Heart Arrest, Sport Injury, Inflammatory Response
What is being tested?: 140kms cycling
How many people: 94 participants
Where: 1 siteIndonesia
Study dates: 28 Oct 2017to 5 May 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 25 to 55 years
Men only
Healthy volunteers accepted
Adult

Study population: participants of Tour de Borobudur Indonesia 2017

Who may be able to join

minimum sample size of 80 men, non athlete, participants of TdB
Classified into two groups: 160kms cycling and 100kms cycling participation
25-55 years old
voluntary participate in the research
eligible in pre participatory physical examination and ECG test by doctor have no history of previous acute coronary syndrome (ACS)

Who cannot join

stop cycling before finish line due to mechanical or bicycle related errors
(subjects who stop cycling due to any physical symptoms and health related problem included in analysis)

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Universitas Negeri Semarang
Semarang, Central Java, 50229

Other trials in Indonesia

About this study

Official title: Predictors of Cardiac Troponin Release After Tour de Borobudur 2017

Read the detailed description

Eligible Criteria:

minimum sample size of 80 men, non-athlete, participants of TdB
Classified into two groups: 160kms cycling and 100kms cycling participation
25-55 years old
voluntary participate in the research
eligible in pre participatory physical examination and ECG test by the doctor
have no history of the previous acute coronary syndrome (ACS)

Measurements:

Interview for determining predictors of sports participation history, medical history, family medical history and Rate of Perceived Exertion Measurement and examination to determine: anthropometry parameters, clinical conditions (Systolic BP, Diastolic BP, hemoglobin levels, T-cholesterol and HDL-C levels, the intensity in cycling activities (mileage, velocity, duration, and time for resting), hemodynamic responses (average and maximum heart rate, Karvonen Index), and Hydration status

Other outcome measurements; pre and post-TdB 2017 measurements of cTnI, MDA, and hs-CRP

Conditions: Heart Arrest, Sport Injury, Inflammatory Response, Oxidative Stress
Being tested: 140kms cycling
Keywords: troponin-I, hs-CRP, Malondialdehyde, predictors
Medical subject headings: Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

140kms cyclingOther
Also called medical history, sports participation history, clinical appearance, lipid profile status
Main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms, and 240kms (investigator did not give any treatment/intervention, just observed the cycling touring event)

Study groups in NCT03310450
Study group	Role	What they receive
Group 140kms cycling		Participants of Tour de Borobudur 2017 140 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated Receives: Other: 140kms cycling
Group 100kms cycling		Participants of Tour de Borobudur 2017 100 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated Receives: Other: 140kms cycling
Group 240kms cycling		Participants of North Coast 2017 240 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated Receives: Other: 140kms cycling

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac Troponin I (cTnI)
specific protein to determine cardiac injury
Measured: immediate after TdB 2017 cycling touring within less than 5 min
Malondialdehyde (MDA)
oxydative stress marker
Measured: immediate after TdB 2017 cycling touring within less than 5 min

Secondary outcomes (2)

High Sensitivity C Reactive Protein (Hs-CRP)
a biomarker that represents the inflammation process
Measured: immediate after TdB 2017 cycling touring within less than 5 min
Number of Participants With Pathological ECG Appearance
Number of Participants with Pathological ECG Appearance.
Pathological ECG appearance was the results of the ECG test describing one of the pathological appearances in ECG i.e.:
1. The pathological rhythm which is may consist of Atrial Flutter, Atrial Fibrillation, Supraventricular Tachycardia, Ventricular Fibrillation, First Degree Heart Block, Second Degree Heart Block, Type 1 - Mobitz I, Second Degree Heart Block, Type 2 - Mobitz II, Third Degree Heart Block, or other pathological rhythm appearances
2. Pathological ST-segment i.e. ST elevation (early repolarization), or another form
3. Pathological U wave, and
4. other pathological appearances
Measured: immediate after TdB 2017 cycling touring within less than 5 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 20175 May 2018

First posted16 Oct 2017
Study start28 Oct 2017
Primary completion11 Nov 2017
Study completion5 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Heart ArrestStudies 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: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03310450
Sponsor's protocol ID: 0017
Acronym: TdBTS
Status last verified: Oct 2019
First submitted: 2 Oct 2017
Last updated: 10 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Serrano-Ostariz E, Terreros-Blanco JL, Legaz-Arrese A, George K, Shave R, Bocos-Terraz P, Izquierdo-Alvarez S, Bancalero JL, Echavarri JM, Quilez J, Aragones MT, Carranza-Garcia LE. The impact of exercise duration and intensity on the release of cardiac biomarkers. Scand J Med Sci Sports. 2011 Apr;21(2):244-9. doi: 10.1111/j.1600-0838.2009.01042.x.
PubMed 19919634
Grande G, Romppel M, Glaesmer H, Petrowski K, Herrmann-Lingen C. The type-D scale (DS14) - Norms and prevalence of type-D personality in a population-based representative sample in Germany. Pers Individ Dif [Internet]. 2010;48(8):935-9. Available from: http://dx.doi.org/10.1016/j.paid.2010.02.026
Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
PubMed 22018588
Kleinbaum DG, Kupper LL, Morgenstern H. Epidemiologic research; Principles and quantitative methods. New York: John Wiley and Son Inc; 1982. 1-527 p.
Bahrudin U, Morikawa K, Takeuchi A, Kurata Y, Miake J, Mizuta E, Adachi K, Higaki K, Yamamoto Y, Shirayoshi Y, Yoshida A, Kato M, Yamamoto K, Nanba E, Morisaki H, Morisaki T, Matsuoka S, Ninomiya H, Hisatome I. Impairment of ubiquitin-proteasome system by E334K cMyBPC modifies channel proteins, leading to electrophysiological dysfunction. J Mol Biol. 2011 Nov 4;413(4):857-78. doi: 10.1016/j.jmb.2011.09.006. Epub 2011 Sep 12.
PubMed 21939669
Bahrudin U, Morisaki H, Morisaki T, Ninomiya H, Higaki K, Nanba E, Igawa O, Takashima S, Mizuta E, Miake J, Yamamoto Y, Shirayoshi Y, Kitakaze M, Carrier L, Hisatome I. Ubiquitin-proteasome system impairment caused by a missense cardiac myosin-binding protein C mutation and associated with cardiac dysfunction in hypertrophic cardiomyopathy. J Mol Biol. 2008 Dec 26;384(4):896-907. doi: 10.1016/j.jmb.2008.09.070. Epub 2008 Oct 7.
PubMed 18929575
Purwowiyoto SL, Aryadi A, Suryaatmadja B, Ruray D, Purwowiyoto BS, Siswanto BB. Positive correlation between ECG dispersion mapping (heartvueTM) with T2DM patients. Glob Heart [Internet]. 2014;9(1):e243. Available from: http://linkinghub.elsevier.com/retrieve/pii/S221181601402119X
de Koning L, Merchant AT, Pogue J, Anand SS. Waist circumference and waist-to-hip ratio as predictors of cardiovascular events: meta-regression analysis of prospective studies. Eur Heart J. 2007 Apr;28(7):850-6. doi: 10.1093/eurheartj/ehm026. Epub 2007 Apr 2.
PubMed 17403720
Shave R, George KP, Atkinson G, Hart E, Middleton N, Whyte G, Gaze D, Collinson PO. Exercise-induced cardiac troponin T release: a meta-analysis. Med Sci Sports Exerc. 2007 Dec;39(12):2099-106. doi: 10.1249/mss.0b013e318153ff78.
PubMed 18046180
Morrow DA. Troponins in patients with acute coronary syndromes: biologic, diagnostic, and therapeutic implications. Cardiovasc Toxicol. 2001;1(2):105-10. doi: 10.1385/ct:1:2:105.
PubMed 12213981
Jassal DS, Moffat D, Krahn J, Ahmadie R, Fang T, Eschun G, Sharma S. Cardiac injury markers in non-elite marathon runners. Int J Sports Med. 2009 Feb;30(2):75-9. doi: 10.1055/s-0028-1104572. Epub 2009 Jan 28.
PubMed 19177312
Rodondi N, Marques-Vidal P, Butler J, Sutton-Tyrrell K, Cornuz J, Satterfield S, Harris T, Bauer DC, Ferrucci L, Vittinghoff E, Newman AB; Health, Aging, and Body Composition Study. Markers of atherosclerosis and inflammation for prediction of coronary heart disease in older adults. Am J Epidemiol. 2010 Mar 1;171(5):540-9. doi: 10.1093/aje/kwp428. Epub 2010 Jan 28.
PubMed 20110287
Eijsvogels TM, Hoogerwerf MD, Maessen MF, Seeger JP, George KP, Hopman MT, Thijssen DH. Predictors of cardiac troponin release after a marathon. J Sci Med Sport. 2015 Jan;18(1):88-92. doi: 10.1016/j.jsams.2013.12.002. Epub 2014 Jan 2.
PubMed 24440407
Serrano-Ostariz E, Legaz-Arrese A, Terreros-Blanco JL, Lopez-Ramon M, Cremades-Arroyos D, Carranza-Garcia LE, Izquierdo-Alvarez S, Bocos-Terraz P. Cardiac biomarkers and exercise duration and intensity during a cycle-touring event. Clin J Sport Med. 2009 Jul;19(4):293-9. doi: 10.1097/JSM.0b013e3181ab3c9d.
PubMed 19638823
Eijsvogels T, George K, Shave R, Gaze D, Levine BD, Hopman MT, Thijssen DH. Effect of prolonged walking on cardiac troponin levels. Am J Cardiol. 2010 Jan 15;105(2):267-72. doi: 10.1016/j.amjcard.2009.08.679.
PubMed 20102930

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Heart Arrest trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predictors of Cardiac Troponin Release After Tour de Borobudur 2017
ClinicalTrials.gov ID: NCT03310450
Acronym / sponsor ID: TdBTS / 0017
Conditions: Heart Arrest, Sport Injury, Inflammatory Response, Oxidative Stress
Keywords: troponin-I, hs-CRP, Malondialdehyde, predictors
Study type: Observational
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Universitas Negeri SemarangUniversity, hospital or other
Collaborators: Ministry of Research, Technology and Higher Education, Republic of Indonesia, Universitas Diponegoro
Study start: 28 Oct 2017 (actual)
Primary completion: 11 Nov 2017 (actual)
Study completion: 5 May 2018 (actual)
First posted: 16 Oct 2017 (actual)
Results: Posted 2 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Eligible Criteria:

minimum sample size of 80 men, non-athlete, participants of TdB
Classified into two groups: 160kms cycling and 100kms cycling participation
25-55 years old
voluntary participate in the research
eligible in pre participatory physical examination and ECG test by the doctor
have no history of the previous acute coronary syndrome (ACS)

Measurements:

Other outcome measurements; pre and post-TdB 2017 measurements of cTnI, MDA, and hs-CRP

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Group 140kms cycling	–	Other: 140kms cyclingParticipants of Tour de Borobudur 2017 140 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated
Group 100kms cycling	–	Other: 140kms cyclingParticipants of Tour de Borobudur 2017 100 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated
Group 240kms cycling	–	Other: 140kms cyclingParticipants of North Coast 2017 240 km cycling touring and willing to participate in the study. Investigator did not give any intervention, just observed the cycling touring event that the subjects participated

Who may qualify

Ages: 25 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult
Study population: participants of Tour de Borobudur Indonesia 2017

Key inclusion criteria (5 listed)

minimum sample size of 80 men, non athlete, participants of TdB
Classified into two groups: 160kms cycling and 100kms cycling participation
25-55 years old
voluntary participate in the research
eligible in pre participatory physical examination and ECG test by doctor have no history of previous acute coronary syndrome (ACS)

Key exclusion criteria (2 listed)

stop cycling before finish line due to mechanical or bicycle related errors
(subjects who stop cycling due to any physical symptoms and health related problem included in analysis)

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
140kms cyclingAlso: medical history, sports participation history, clinical appearance, lipid profile statusMain exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms, and 240kms (investigator did not give any treatment/intervention, just observed the cycling touring event)	Other	Group 100kms cycling, Group 140kms cycling, Group 240kms cycling

Primary outcome

Cardiac Troponin I (cTnI)
Time frame: immediate after TdB 2017 cycling touring within less than 5 min
specific protein to determine cardiac injury
Malondialdehyde (MDA)
Time frame: immediate after TdB 2017 cycling touring within less than 5 min
oxydative stress marker

2 secondary outcomes

High Sensitivity C Reactive Protein (Hs-CRP)
Time frame: immediate after TdB 2017 cycling touring within less than 5 min
Number of Participants With Pathological ECG Appearance
Time frame: immediate after TdB 2017 cycling touring within less than 5 min

Results and safety

Results posted to the registry on 2 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 140kms Cycling	32	30
Group 100kms Cycling	34	30
Group 240kms Cycling	28	28

Primary outcome: Cardiac Troponin I (cTnI)

Time frame: immediate after TdB 2017 cycling touring within less than 5 min. Mean (Standard Deviation). Unit: ng/dL

Measure	Group 140kms Cycling n = 30	Group 100kms Cycling n = 30	Group 240kms Cycling n = 28
Value	6.6 (46.6)	10.1 (10.44)	25.0 (61.39)

Primary outcome: Malondialdehyde (MDA)

Time frame: immediate after TdB 2017 cycling touring within less than 5 min. Mean (Standard Deviation). Unit: mcmol/mL

Measure	Group 140kms Cycling n = 30	Group 100kms Cycling n = 30	Group 240kms Cycling n = 28
Value	206.1 (116.84)	196.4 (68.59)	231.2 (105.54)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: during the event (cycling activity of TdB and NC) i.e. 6.1 hours range 3.5-9.8 and 24 hours after the event. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 140kms Cycling	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Group 100kms Cycling	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Group 240kms Cycling	0 of 28 (0%)	0 of 28 (0%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19919634Serrano-Ostariz E, Terreros-Blanco JL, Legaz-Arrese A, George K, Shave R, Bocos-Terraz P, Izquierdo-Alvarez S, Bancalero JL, Echavarri JM, Quilez J, Aragones MT, Carranza-Garcia LE. The impact of exercise duration and intensity on the release of cardiac biomarkers. Scand J Med Sci Sports. 2011 Apr;21(2):244-9. doi: 10.1111/j.1600-0838.2009.01042.x.
BackgroundGrande G, Romppel M, Glaesmer H, Petrowski K, Herrmann-Lingen C. The type-D scale (DS14) - Norms and prevalence of type-D personality in a population-based representative sample in Germany. Pers Individ Dif [Internet]. 2010;48(8):935-9. Available from: http://dx.doi.org/10.1016/j.paid.2010.02.026
Background: PubMed 22018588Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115.
BackgroundKleinbaum DG, Kupper LL, Morgenstern H. Epidemiologic research; Principles and quantitative methods. New York: John Wiley and Son Inc; 1982. 1-527 p.
Background: PubMed 21939669Bahrudin U, Morikawa K, Takeuchi A, Kurata Y, Miake J, Mizuta E, Adachi K, Higaki K, Yamamoto Y, Shirayoshi Y, Yoshida A, Kato M, Yamamoto K, Nanba E, Morisaki H, Morisaki T, Matsuoka S, Ninomiya H, Hisatome I. Impairment of ubiquitin-proteasome system by E334K cMyBPC modifies channel proteins, leading to electrophysiological dysfunction. J Mol Biol. 2011 Nov 4;413(4):857-78. doi: 10.1016/j.jmb.2011.09.006. Epub 2011 Sep 12.
Background: PubMed 18929575Bahrudin U, Morisaki H, Morisaki T, Ninomiya H, Higaki K, Nanba E, Igawa O, Takashima S, Mizuta E, Miake J, Yamamoto Y, Shirayoshi Y, Kitakaze M, Carrier L, Hisatome I. Ubiquitin-proteasome system impairment caused by a missense cardiac myosin-binding protein C mutation and associated with cardiac dysfunction in hypertrophic cardiomyopathy. J Mol Biol. 2008 Dec 26;384(4):896-907. doi: 10.1016/j.jmb.2008.09.070. Epub 2008 Oct 7.
BackgroundPurwowiyoto SL, Aryadi A, Suryaatmadja B, Ruray D, Purwowiyoto BS, Siswanto BB. Positive correlation between ECG dispersion mapping (heartvueTM) with T2DM patients. Glob Heart [Internet]. 2014;9(1):e243. Available from: http://linkinghub.elsevier.com/retrieve/pii/S221181601402119X
Background: PubMed 17403720de Koning L, Merchant AT, Pogue J, Anand SS. Waist circumference and waist-to-hip ratio as predictors of cardiovascular events: meta-regression analysis of prospective studies. Eur Heart J. 2007 Apr;28(7):850-6. doi: 10.1093/eurheartj/ehm026. Epub 2007 Apr 2.
Background: PubMed 18046180Shave R, George KP, Atkinson G, Hart E, Middleton N, Whyte G, Gaze D, Collinson PO. Exercise-induced cardiac troponin T release: a meta-analysis. Med Sci Sports Exerc. 2007 Dec;39(12):2099-106. doi: 10.1249/mss.0b013e318153ff78.
Background: PubMed 12213981Morrow DA. Troponins in patients with acute coronary syndromes: biologic, diagnostic, and therapeutic implications. Cardiovasc Toxicol. 2001;1(2):105-10. doi: 10.1385/ct:1:2:105.
Background: PubMed 19177312Jassal DS, Moffat D, Krahn J, Ahmadie R, Fang T, Eschun G, Sharma S. Cardiac injury markers in non-elite marathon runners. Int J Sports Med. 2009 Feb;30(2):75-9. doi: 10.1055/s-0028-1104572. Epub 2009 Jan 28.
Background: PubMed 20110287Rodondi N, Marques-Vidal P, Butler J, Sutton-Tyrrell K, Cornuz J, Satterfield S, Harris T, Bauer DC, Ferrucci L, Vittinghoff E, Newman AB; Health, Aging, and Body Composition Study. Markers of atherosclerosis and inflammation for prediction of coronary heart disease in older adults. Am J Epidemiol. 2010 Mar 1;171(5):540-9. doi: 10.1093/aje/kwp428. Epub 2010 Jan 28.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mahalul Azam, Dr principal investigator

Universitas Negeri Semarang

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 Heart Arrest and Sport Injury, run by Universitas Negeri Semarang at 1 site in Indonesia.

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 5 inclusion and 2 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: finished, as of the sponsor's last update on 10 Oct 2019. 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 Indonesia. 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?

Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac Troponin I (cTnI) (time frame: immediate after TdB 2017 cycling touring within less than 5 min). 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 NCT03310450, which also lists 16 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 10 Oct 2019.