HypertensionNCT02809040
E_Stethoscope: Portable Digital Auscultation Study on Hypertensive/Hypertensive Heart Disease Patients
An observational study of Hypertension and Hypertensive Heart Disease, run by National Heart Centre Singapore at 1 site in Singapore.
Trial summary
Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to high blood pressure. In patients with HHD, abnormalities in the way heart muscle relaxes and how heart chambers passively fill with blood (diastolic dysfunction) can occur that may be detected on echocardiography (echo), which… Read more about this study
- Who is it for?
- Ages 21 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hypertensive Heart Disease
- What is being tested?
- Electrocardiogram/Echocardiography and Portable digital auscultation
- How many people
- 60 participants
- Where
- 1 siteSingapore
- Study dates
- Feb 2015to May 2018
- 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 21 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from primary care clinic and outpatient clinics from the National Heart Centre Singapore.
Who may be able to join
- Participants with clinically suspected or known HT/Hypertensive Heart Disease who have been scheduled for echocardiography examination and/or cardiac catheterization.
- Participants with history of high BP and stable medication for at least 2 weeks.
- Presence of the following :
- Elevated BP measurement or Left ventricular hypertrophy (LVH) on either prior ECG or prior echo.
Who cannot join
- Participants with heart muscle disease.
- Participants with significance valve disease.
- Strictly exclude hypertensive for Normal healthy volunteers.
- Not on any anti-hypertensive agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E_Stethoscope : Portable Digital Auscultation Based on Wireless Sensor Node to Diagnose Diastolic Dysfunction in Hypertensive Heart Disease
Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to high blood pressure. In patients with HHD, abnormalities in the way heart muscle relaxes and how heart chambers passively fill with blood (diastolic dysfunction) can occur that may be detected on echocardiography (echo), which is a standard clinical method to examine heart structure and function using reflected sound waves. Investigators propose to develop a digital auscultation system or electronic stethoscope based on wireless sensor node technique. Investigators hypothesize that the heart sounds measurements detected by electronic stethoscope can be used to detect heart diastolic dysfunction in HHD .
Read the detailed description
Study proposal aims to look into treatment of hypertension (HT) and its complications of the exact high healthcare costs. In 2004, Singapore adult prevalence of hypertension was 20.1%. World Health Organization estimates that HT causes 4.5% of global disease burden, and that 62% of cerebrovascular disease and 49% of ischemic heart disease are attributable to suboptimal blood pressure (BP) control.
Recently, scrutiny has been focused on appropriate BP levels at which to initiate HT treatment with the benefit of strict BP targets in otherwise uncomplicated HT is questioned, as HT drug treatment is not without risks. This underscores the need to stratify hypertension patients according to target organ damage, so that affected HT patients may be selected for intensive BP lowering.
Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to high BP. As population ages, both HT and Hypertensive Heart Disease prevalence increase. Genetic and hemodynamic factors interact to cause Hypertensive Heart Disease in patients with hypertension. In patients with Hypertensive Heart Disease , abnormalities of both myocardial relaxation and passive filling may be detected sometimes on echocardiography (echo). These diastolic dysfunctions are due to various mechanisms but central to the pathophysiology is an increase in myocardial stiffness. Early symptoms of myocardial stiffness caused by left ventricular hypertrophy (LVH) is a good early indicator for cardiovascular target organ damage in patients with HT and Hypertensive Heart Disease . Hypertensive Heart Disease patients constitute a group in which intensive BP treatment with drugs to strict targets are shown to yield favourable benefit risk ratios. As such, the identification of Hypertensive Heart Disease patients becomes paramount.
An electrocardiogram (ECG) monitors and records the heart's electrical activity. ECG is insensitive to detect diastolic dysfunction with sensitivity from 12% to 50%. An echo takes a picture of the heart using ultrasound. Echo can be used to diagnose diastolic function, however, no one single echo parameter can make the diagnosis. Multiple echo parameters have been proposed including mitral inflow velocity pattern, pulmonary vein flow patterns and tissue Doppler measurements, but imprecise. Existing ultrasound scans cost in the range of US$300-$600 which are reimbursable under Medicaid (the payer). A coronary angiography examines the flow of blood through the heart by inserting a catheter into the heart. It is too invasive and too costly. Therefore, there is appealing need to have a cheaper non-invasive solution that would be able to detect diastolic function. That will have largest impact on patients management and on payers.
A cheap, non-invasive and sensitive solution that permits detection via auscultation of abnormal heart sounds, indicating stiff heart muscle associated with Hypertensive Heart Disease among HT patients is critically needed. Cardiac auscultation (listening to heart sounds) is possible option as heart sounds are associated with myocardial function and dysfunction .In a normal heart, two heart sounds (S1 and S2) are audible, corresponding to closure of the mitral and aortic heart valves respectively. A third heart sound S3, occurring after S2 is present in some heart failure. A fourth heart sound S4, occurring just before S1, is due to forceful contraction of the atrium to overcome a stiff or hypertrophic left ventricle . Human ears are not well equipped to detect such abnormities consistently with a conventional stethoscope. Therefore, investigators propose to develop a low power, non-invasive, portable device which is based on Wireless Sensor Node (WSN) technology to achieve our goal of portable auscultation.Proposed device will allow a monitoring/recording of heart sounds in-situ and perform preliminary assessment of diastolic function that is physiologically meaningful, reproducible and validated. Multiple devices can also be placed and used concurrently at different sites over the torso to enhance chances of detecting abnormal heart sounds.
- Conditions
- Hypertension, Hypertensive Heart Disease
- Being tested
- Electrocardiogram/Echocardiography, Portable digital auscultation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram/EchocardiographyOther
Electrocardiogram (ECG) is a non-invasive (does not require an incision into the body) test that records the electrical activity of the heart.
Echocardiography is a non-invasive scanning of heart images using standard two-dimensional, three-dimensional, and Doppler ultrasound to create images of the heart.
Portable digital auscultationOther
Traditional Stethoscope :An acoustic medical device for auscultation, or listening to internal sounds of human body.
Digital Stethoscope :Electronic stethoscope is a passive heart sound recording device. The heart sound listening and recording will be performed by trained personnel in a way very similar to that of using conventional cardiac auscultation
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive Heart Disease | Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope Receives: Other: Electrocardiogram/Echocardiography; Other: Portable digital auscultation | |
| Volunteer subjects | Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope Receives: Other: Electrocardiogram/Echocardiography; Other: Portable digital auscultation | |
| Diagnosed Hypertension | Portable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope Receives: Other: Electrocardiogram/Echocardiography; Other: Portable digital auscultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart sound measurement from proposed device will be correlated with diastolic functional parameters from echo result and cardiac catheterization.
Heart sound measurement will be correlated with End diastolic pressure from cardiac catheterisation.
Measured: Through study completion (October 2016)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startFeb 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- A/Prof Tan Ru San, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809040
- Sponsor's protocol ID
- 2014/2083
- Status last verified
- Jul 2017
- First submitted
- 31 May 2016
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Whitworth JA; World Health Organization, International Society of Hypertension Writing Group. 2003 World Health Organization (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens. 2003 Nov;21(11):1983-92. doi: 10.1097/00004872-200311000-00002.
PubMed 14597836James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.
PubMed 24352797Diamond JA, Phillips RA. Hypertensive heart disease. Hypertens Res. 2005 Mar;28(3):191-202. doi: 10.1291/hypres.28.191.
PubMed 16097361Zannad F, Dousset B, Alla F. Treatment of congestive heart failure: interfering the aldosterone-cardiac extracellular matrix relationship. Hypertension. 2001 Nov;38(5):1227-32. doi: 10.1161/hy1101.099484.
PubMed 11711528Levy D, Garrison RJ, Savage DD, Kannel WB, Castelli WP. Prognostic implications of echocardiographically determined left ventricular mass in the Framingham Heart Study. N Engl J Med. 1990 May 31;322(22):1561-6. doi: 10.1056/NEJM199005313222203.
PubMed 2139921Drazner MH, Rame JE, Marino EK, Gottdiener JS, Kitzman DW, Gardin JM, Manolio TA, Dries DL, Siscovick DS. Increased left ventricular mass is a risk factor for the development of a depressed left ventricular ejection fraction within five years: the Cardiovascular Health Study. J Am Coll Cardiol. 2004 Jun 16;43(12):2207-15. doi: 10.1016/j.jacc.2003.11.064.
PubMed 15193681Lorell BH, Carabello BA; New Collective Author. Left ventricular hypertrophy: pathogenesis, detection, and prognosis. Circulation. 2000 Jul 25;102(4):470-9. doi: 10.1161/01.cir.102.4.470. No abstract available.
PubMed 10908222Marcus GM, Vessey J, Jordan MV, Huddleston M, McKeown B, Gerber IL, Foster E, Chatterjee K, McCulloch CE, Michaels AD. Relationship between accurate auscultation of a clinically useful third heart sound and level of experience. Arch Intern Med. 2006 Mar 27;166(6):617-22. doi: 10.1001/archinte.166.6.617.
PubMed 16567599Shah SJ, Nakamura K, Marcus GM, Gerber IL, McKeown BH, Jordan MV, Huddleston M, Foster E, Michaels AD. Association of the fourth heart sound with increased left ventricular end-diastolic stiffness. J Card Fail. 2008 Jun;14(5):431-6. doi: 10.1016/j.cardfail.2008.01.010. Epub 2008 May 27.
PubMed 18514937
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E_Stethoscope : Portable Digital Auscultation Based on Wireless Sensor Node to Diagnose Diastolic Dysfunction in Hypertensive Heart Disease
- ClinicalTrials.gov ID
- NCT02809040
- Acronym / sponsor ID
- 2014/2083
- Conditions
- Hypertension, Hypertensive Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 22 Jun 2016 (estimated)
- 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.
Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to high blood pressure. In patients with HHD, abnormalities in the way heart muscle relaxes and how heart chambers passively fill with blood (diastolic dysfunction) can occur that may be detected on echocardiography (echo), which is a standard clinical method to examine heart structure and function using reflected sound waves. Investigators propose to develop a digital auscultation system or electronic stethoscope based on wireless sensor node technique. Investigators hypothesize that the heart sounds measurements detected by electronic stethoscope can be used to detect heart diastolic dysfunction in HHD .
Detailed description
Study proposal aims to look into treatment of hypertension (HT) and its complications of the exact high healthcare costs. In 2004, Singapore adult prevalence of hypertension was 20.1%. World Health Organization estimates that HT causes 4.5% of global disease burden, and that 62% of cerebrovascular disease and 49% of ischemic heart disease are attributable to suboptimal blood pressure (BP) control.
Recently, scrutiny has been focused on appropriate BP levels at which to initiate HT treatment with the benefit of strict BP targets in otherwise uncomplicated HT is questioned, as HT drug treatment is not without risks. This underscores the need to stratify hypertension patients according to target organ damage, so that affected HT patients may be selected for intensive BP lowering.
Hypertensive heart disease (HHD) is a heart condition that is caused by chronic exposure to high BP. As population ages, both HT and Hypertensive Heart Disease prevalence increase. Genetic and hemodynamic factors interact to cause Hypertensive Heart Disease in patients with hypertension. In patients with Hypertensive Heart Disease , abnormalities of both myocardial relaxation and passive filling may be detected sometimes on echocardiography (echo). These diastolic dysfunctions are due to various mechanisms but central to the pathophysiology is an increase in myocardial stiffness. Early symptoms of myocardial stiffness caused by left ventricular hypertrophy (LVH) is a good early indicator for cardiovascular target organ damage in patients with HT and Hypertensive Heart Disease . Hypertensive Heart Disease patients constitute a group in which intensive BP treatment with drugs to strict targets are shown to yield favourable benefit risk ratios. As such, the identification of Hypertensive Heart Disease patients becomes paramount.
An electrocardiogram (ECG) monitors and records the heart's electrical activity. ECG is insensitive to detect diastolic dysfunction with sensitivity from 12% to 50%. An echo takes a picture of the heart using ultrasound. Echo can be used to diagnose diastolic function, however, no one single echo parameter can make the diagnosis. Multiple echo parameters have been proposed including mitral inflow velocity pattern, pulmonary vein flow patterns and tissue Doppler measurements, but imprecise. Existing ultrasound scans cost in the range of US$300-$600 which are reimbursable under Medicaid (the payer). A coronary angiography examines the flow of blood through the heart by inserting a catheter into the heart. It is too invasive and too costly. Therefore, there is appealing need to have a cheaper non-invasive solution that would be able to detect diastolic function. That will have largest impact on patients management and on payers.
A cheap, non-invasive and sensitive solution that permits detection via auscultation of abnormal heart sounds, indicating stiff heart muscle associated with Hypertensive Heart Disease among HT patients is critically needed. Cardiac auscultation (listening to heart sounds) is possible option as heart sounds are associated with myocardial function and dysfunction .In a normal heart, two heart sounds (S1 and S2) are audible, corresponding to closure of the mitral and aortic heart valves respectively. A third heart sound S3, occurring after S2 is present in some heart failure. A fourth heart sound S4, occurring just before S1, is due to forceful contraction of the atrium to overcome a stiff or hypertrophic left ventricle . Human ears are not well equipped to detect such abnormities consistently with a conventional stethoscope. Therefore, investigators propose to develop a low power, non-invasive, portable device which is based on Wireless Sensor Node (WSN) technology to achieve our goal of portable auscultation.Proposed device will allow a monitoring/recording of heart sounds in-situ and perform preliminary assessment of diastolic function that is physiologically meaningful, reproducible and validated. Multiple devices can also be placed and used concurrently at different sites over the torso to enhance chances of detecting abnormal heart sounds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypertensive Heart Disease | – | Other: Electrocardiogram/Echocardiography, Other: Portable digital auscultationPortable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope |
| Volunteer subjects | – | Other: Electrocardiogram/Echocardiography, Other: Portable digital auscultationPortable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope |
| Diagnosed Hypertension | – | Other: Electrocardiogram/Echocardiography, Other: Portable digital auscultationPortable Digital Auscultation/ Electrocardiogram/Echocardiography/ Traditional Stethoscope |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from primary care clinic and outpatient clinics from the National Heart Centre Singapore.
Key inclusion criteria (4 listed)
- Participants with clinically suspected or known HT/Hypertensive Heart Disease who have been scheduled for echocardiography examination and/or cardiac catheterization.
- Participants with history of high BP and stable medication for at least 2 weeks.
- Presence of the following :
- Elevated BP measurement or Left ventricular hypertrophy (LVH) on either prior ECG or prior echo.
Key exclusion criteria (4 listed)
- Participants with heart muscle disease.
- Participants with significance valve disease.
- Strictly exclude hypertensive for Normal healthy volunteers.
- Not on any anti-hypertensive agents.
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 |
|---|---|---|
| Electrocardiogram/EchocardiographyElectrocardiogram (ECG) is a non-invasive (does not require an incision into the body) test that records the electrical activity of the heart. Echocardiography is a non-invasive scanning of heart images using standard two-dimensional, three-dimensional, and Doppler ultrasound to create images of the heart. | Other | Diagnosed Hypertension, Hypertensive Heart Disease, Volunteer subjects |
| Portable digital auscultationTraditional Stethoscope :An acoustic medical device for auscultation, or listening to internal sounds of human body. Digital Stethoscope :Electronic stethoscope is a passive heart sound recording device. The heart sound listening and recording will be performed by trained personnel in a way very similar to that of using conventional cardiac auscultation | Other | Diagnosed Hypertension, Hypertensive Heart Disease, Volunteer subjects |
Primary outcome
Heart sound measurement from proposed device will be correlated with diastolic functional parameters from echo result and cardiac catheterization.
Time frame: Through study completion (October 2016)
Heart sound measurement will be correlated with End diastolic pressure from cardiac catheterisation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Background: PubMed 14597836Whitworth JA; World Health Organization, International Society of Hypertension Writing Group. 2003 World Health Organization (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens. 2003 Nov;21(11):1983-92. doi: 10.1097/00004872-200311000-00002.
- Background: PubMed 24352797James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427.
- Background: PubMed 16097361Diamond JA, Phillips RA. Hypertensive heart disease. Hypertens Res. 2005 Mar;28(3):191-202. doi: 10.1291/hypres.28.191.
- Background: PubMed 11711528Zannad F, Dousset B, Alla F. Treatment of congestive heart failure: interfering the aldosterone-cardiac extracellular matrix relationship. Hypertension. 2001 Nov;38(5):1227-32. doi: 10.1161/hy1101.099484.
- Background: PubMed 2139921Levy D, Garrison RJ, Savage DD, Kannel WB, Castelli WP. Prognostic implications of echocardiographically determined left ventricular mass in the Framingham Heart Study. N Engl J Med. 1990 May 31;322(22):1561-6. doi: 10.1056/NEJM199005313222203.
- Background: PubMed 15193681Drazner MH, Rame JE, Marino EK, Gottdiener JS, Kitzman DW, Gardin JM, Manolio TA, Dries DL, Siscovick DS. Increased left ventricular mass is a risk factor for the development of a depressed left ventricular ejection fraction within five years: the Cardiovascular Health Study. J Am Coll Cardiol. 2004 Jun 16;43(12):2207-15. doi: 10.1016/j.jacc.2003.11.064.
- Background: PubMed 10908222Lorell BH, Carabello BA; New Collective Author. Left ventricular hypertrophy: pathogenesis, detection, and prognosis. Circulation. 2000 Jul 25;102(4):470-9. doi: 10.1161/01.cir.102.4.470. No abstract available.
- Background: PubMed 16567599Marcus GM, Vessey J, Jordan MV, Huddleston M, McKeown B, Gerber IL, Foster E, Chatterjee K, McCulloch CE, Michaels AD. Relationship between accurate auscultation of a clinically useful third heart sound and level of experience. Arch Intern Med. 2006 Mar 27;166(6):617-22. doi: 10.1001/archinte.166.6.617.
- Background: PubMed 18514937Shah SJ, Nakamura K, Marcus GM, Gerber IL, McKeown BH, Jordan MV, Huddleston M, Foster E, Michaels AD. Association of the fourth heart sound with increased left ventricular end-diastolic stiffness. J Card Fail. 2008 Jun;14(5):431-6. doi: 10.1016/j.cardfail.2008.01.010. Epub 2008 May 27.
- 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. This study is not recruiting at the moment.
A/Prof Tan Ru San principal investigator
National Heart Centre Singapore
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 Hypertension and Hypertensive Heart Disease, run by National Heart Centre Singapore at 1 site in Singapore.
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 4 inclusion and 4 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 14 Jul 2017. 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 Singapore. 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?
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?
Heart sound measurement from proposed device will be correlated with diastolic functional parameters from echo result and cardiac catheterization. (time frame: Through study completion (October 2016)). 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 NCT02809040, which also lists 9 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 14 Jul 2017.