FMD - Flow Mediated DilationNCT03723278
Influence of Nitric Oxide on Flow Mediated Dilation
An observational study of FMD - Flow Mediated Dilation, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Flow-mediated vasodilation (FMD) has become one of the most widely assessed parameter to analyze endothelial function. The peripheral endothelial function as assessed by FMD correlates with coronary artery endothelial function and moreover, impaired FMD has been revealed to be good predictor for cardiovascular events… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- FMD - Flow Mediated Dilation
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 14 Nov 2018to 31 Mar 2019
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: * Young, male and healthy volunteers without any significant disease * Age of 18 and 45 years old
Who may be able to join
- Young, male and healthy volunteers without any significant disease
- Age of 18 and 45 years old
- Informed consent has to be given in written form
Who cannot join
- Uncontrolled hypertension or blood pressure >160/100 mmHg
- Known Diabetes mellitus or fasting plasma glucose >126mg/dl
- Subjects having any chronic treatment
- Drug or alcohol abuse
- Allergies or intolerance against the substances used in the study
- Smokers or subjects had stopped smoking <1 year
- Participation in another clinical study within 30 days prior to V1
- Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 Good Clinical Practice-V
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
Erlangen, 91054
About this study
Official title: Single-centre, Single-blind, Randomized, Controlled, Cross-over Study to Analyze the Influence of Nitric Oxide on Flow Mediated Dilation
Flow-mediated vasodilation (FMD) has become one of the most widely assessed parameter to analyze endothelial function. The peripheral endothelial function as assessed by FMD correlates with coronary artery endothelial function and moreover, impaired FMD has been revealed to be good predictor for cardiovascular events in patients beyond cardiovascular risk factors and in patients with coronary artery disease.
This non-invasive technique measures the ability of the arteries to respond with endothelial release of vasoactive factors during reactive hyperemia. In this study the goal is to analyze in a clinical trial to what extend nitric oxide contribute to FMD by measuring FMD before and after blocking the release of nitric oxide. FMD is measured using a semi-automatic device named UNEX, recently developed in Japan. This semi-automatic ultrasound system represents a new development that overcomes the limitation of classic systems.
Read more
The hypothesis of this study is that FMD response is mostly nitric oxide dependent. To prove this hypothesis, overall 20 healthy male volunteers are included in this study. Total duration of this study for each volunteer is 2-4 weeks with total 3 visits at the Clinical Research Unit (CRC) of the Department of Nephrology, University of Erlangen-Nuremberg.
This study is important to better understand the mechanism of any kind of impaired FMD by cardiovascular risk factors and diseases and to better interpret impaired FMD assessed by UNEX.
Read the detailed description
The assessment of endothelial function is crucial, as its dysfunction is described as a key pathological condition associated with many diseases leading to arteriosclerosis. Flow-mediated vasodilation (FMD) has become one of the most widely assessed parameter to analyze endothelial function. Celermajer et al. was the first to measure the FMD-response in vivo by ultrasound. This non-invasive technique measures the ability of the arteries to respond with endothelial release of vasoactive factors during reactive hyperemia.
The peripheral endothelial function as assessed by FMD correlates with coronary artery endothelial function. Impaired FMD has been revealed to be good predictor for cardiovascular events in patients beyond cardiovascular risk factors and in patients with coronary artery disease. It is also predictive for the extent and severity of coronary atherosclerosis.
Beyond the predictive nature of FMD, several studies have been reported on the effect of pharmacologic or physiologic interventions on FMD. For example weight loss and exercise increased FMD in overweight and obese patients with coronary heart disease.
Impaired FMD is mainly characterized by reduced bioavailability of different vasodilators due to oxidative stress. Of these vasodilators nitric oxide plays the major role, but its contribution to FMD is inconclusive. Studies to clarify the role of nitric oxide on FMD have been done with various methods, which require extensive training and standardization. Operator, study preparation, image acquisition and site selection, sphygmomanometer probe position, cuff occlusion time, the accurate use of edge-detection software as well as the correct characterization of the FMD response are all factors, which influence FMD measurement.
In this study the goal is to analyze in a clinical trial to what extent nitric oxide contribute to FMD by measuring FMD before and after blocking the release of nitric oxide. FMD is measured using a semi-automatic device named UNEX, recently developed in Japan. FMD measurements using UNEX implement the standards described in guidelines. This semi-automatic ultrasound system using an H-type ultrasound probe represents a new development that overcomes the limitation of classic systems (in particular the investigator-dependency of conventional, "hand-held" FMD measurements). This system comprised a 7.5-megahertz linear array transducer and a novel stereotactic probe-holding device (UNEX Co., Nagoya, Japan). Another advantage of this device is the continuous recording of B-mode images and A-mode waves of the artery in the longitudinal plane, so that continuous measurement of arterial diameter in the 4.5 min following cuff deflation occurs. A meta-analysis described that the nitric oxide dependency of the FMD response was the most in studies with FMD measurements at brachial artery with distal placement of the cuff and 5-minute occlusion. These criteria are fulfilled by UNEX. However, no data on nitric oxide dependency are available in the literature. Finally, this semi-automatic assessment of FMD has been shown to improve the precision and repeatability of the measurements.
The hypothesis of this study is that FMD response is mostly nitric oxide dependent and this could not be proven so far due to less sensitive conventional tool of FMD measurement.
- Conditions
- FMD - Flow Mediated Dilation
- Keywords
- nitric oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Young, male and healthy volunteers without any significant disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of flow mediated dilation
Percent change of flow mediated dilation (UNEX EF) in Response to L-NMMA/Saline infusion
Measured: 1 week after study inclusion
Percent change of flow mediated dilation
Percent change of flow mediated dilation (UNEX EF) in Response to L-NMMA/Saline infusion
Measured: 2 weeks after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start14 Nov 2018
- Primary completion1 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for FMD - Flow Mediated DilationStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723278
- Sponsor's protocol ID
- CRC2018UNEX
- Status last verified
- Feb 2020
- First submitted
- 11 Oct 2018
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Makimattila S, Virkamaki A, Groop PH, Cockcroft J, Utriainen T, Fagerudd J, Yki-Jarvinen H. Chronic hyperglycemia impairs endothelial function and insulin sensitivity via different mechanisms in insulin-dependent diabetes mellitus. Circulation. 1996 Sep 15;94(6):1276-82. doi: 10.1161/01.cir.94.6.1276.
PubMed 8822980Panza JA, Quyyumi AA, Brush JE Jr, Epstein SE. Abnormal endothelium-dependent vascular relaxation in patients with essential hypertension. N Engl J Med. 1990 Jul 5;323(1):22-7. doi: 10.1056/NEJM199007053230105.
PubMed 2355955Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.
PubMed 1359209Anderson TJ, Uehata A, Gerhard MD, Meredith IT, Knab S, Delagrange D, Lieberman EH, Ganz P, Creager MA, Yeung AC, et al. Close relation of endothelial function in the human coronary and peripheral circulations. J Am Coll Cardiol. 1995 Nov 1;26(5):1235-41. doi: 10.1016/0735-1097(95)00327-4.
PubMed 7594037Yeboah J, Crouse JR, Hsu FC, Burke GL, Herrington DM. Brachial flow-mediated dilation predicts incident cardiovascular events in older adults: the Cardiovascular Health Study. Circulation. 2007 May 8;115(18):2390-7. doi: 10.1161/CIRCULATIONAHA.106.678276. Epub 2007 Apr 23.
PubMed 17452608Neunteufl T, Katzenschlager R, Hassan A, Klaar U, Schwarzacher S, Glogar D, Bauer P, Weidinger F. Systemic endothelial dysfunction is related to the extent and severity of coronary artery disease. Atherosclerosis. 1997 Feb 28;129(1):111-8. doi: 10.1016/s0021-9150(96)06018-2.
PubMed 9069525Ades PA, Savage PD, Lischke S, Toth MJ, Harvey-Berino J, Bunn JY, Ludlow M, Schneider DJ. The effect of weight loss and exercise training on flow-mediated dilatation in coronary heart disease: a randomized trial. Chest. 2011 Dec;140(6):1420-1427. doi: 10.1378/chest.10-3289. Epub 2011 Jul 21.
PubMed 21778256Joannides R, Haefeli WE, Linder L, Richard V, Bakkali EH, Thuillez C, Luscher TF. Nitric oxide is responsible for flow-dependent dilatation of human peripheral conduit arteries in vivo. Circulation. 1995 Mar 1;91(5):1314-9. doi: 10.1161/01.cir.91.5.1314.
PubMed 7867167Green DJ, Dawson EA, Groenewoud HM, Jones H, Thijssen DH. Is flow-mediated dilation nitric oxide mediated?: A meta-analysis. Hypertension. 2014 Feb;63(2):376-82. doi: 10.1161/HYPERTENSIONAHA.113.02044. Epub 2013 Nov 25.
PubMed 24277765Iguchi T, Takemoto Y, Shimada K, Matsumoto K, Nakanishi K, Otsuka K, Hyodo E, Hirohashi K, Tahara A, Yoshiyama M. Simultaneous assessment of endothelial function and morphology in the brachial artery using a new semiautomatic ultrasound system. Hypertens Res. 2013 Aug;36(8):691-7. doi: 10.1038/hr.2013.35. Epub 2013 Apr 18.
PubMed 23595043Tomiyama H, Kohro T, Higashi Y, Takase B, Suzuki T, Ishizu T, Ueda S, Yamazaki T, Furumoto T, Kario K, Inoue T, Koba S, Watanabe K, Takemoto Y, Hano T, Sata M, Ishibashi Y, Node K, Maemura K, Ohya Y, Furukawa T, Ito H, Ikeda H, Yamashina A. Reliability of measurement of endothelial function across multiple institutions and establishment of reference values in Japanese. Atherosclerosis. 2015 Oct;242(2):433-42. doi: 10.1016/j.atherosclerosis.2015.08.001. Epub 2015 Aug 5.
PubMed 26291496
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre, Single-blind, Randomized, Controlled, Cross-over Study to Analyze the Influence of Nitric Oxide on Flow Mediated Dilation
- ClinicalTrials.gov ID
- NCT03723278
- Acronym / sponsor ID
- CRC2018UNEX
- Conditions
- FMD - Flow Mediated Dilation
- Keywords
- nitric oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 29 Oct 2018 (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.
Flow-mediated vasodilation (FMD) has become one of the most widely assessed parameter to analyze endothelial function. The peripheral endothelial function as assessed by FMD correlates with coronary artery endothelial function and moreover, impaired FMD has been revealed to be good predictor for cardiovascular events in patients beyond cardiovascular risk factors and in patients with coronary artery disease.
This non-invasive technique measures the ability of the arteries to respond with endothelial release of vasoactive factors during reactive hyperemia. In this study the goal is to analyze in a clinical trial to what extend nitric oxide contribute to FMD by measuring FMD before and after blocking the release of nitric oxide. FMD is measured using a semi-automatic device named UNEX, recently developed in Japan. This semi-automatic ultrasound system represents a new development that overcomes the limitation of classic systems.
The hypothesis of this study is that FMD response is mostly nitric oxide dependent. To prove this hypothesis, overall 20 healthy male volunteers are included in this study. Total duration of this study for each volunteer is 2-4 weeks with total 3 visits at the Clinical Research Unit (CRC) of the Department of Nephrology, University of Erlangen-Nuremberg.
This study is important to better understand the mechanism of any kind of impaired FMD by cardiovascular risk factors and diseases and to better interpret impaired FMD assessed by UNEX.
Detailed description
The assessment of endothelial function is crucial, as its dysfunction is described as a key pathological condition associated with many diseases leading to arteriosclerosis. Flow-mediated vasodilation (FMD) has become one of the most widely assessed parameter to analyze endothelial function. Celermajer et al. was the first to measure the FMD-response in vivo by ultrasound. This non-invasive technique measures the ability of the arteries to respond with endothelial release of vasoactive factors during reactive hyperemia.
The peripheral endothelial function as assessed by FMD correlates with coronary artery endothelial function. Impaired FMD has been revealed to be good predictor for cardiovascular events in patients beyond cardiovascular risk factors and in patients with coronary artery disease. It is also predictive for the extent and severity of coronary atherosclerosis.
Beyond the predictive nature of FMD, several studies have been reported on the effect of pharmacologic or physiologic interventions on FMD. For example weight loss and exercise increased FMD in overweight and obese patients with coronary heart disease.
Impaired FMD is mainly characterized by reduced bioavailability of different vasodilators due to oxidative stress. Of these vasodilators nitric oxide plays the major role, but its contribution to FMD is inconclusive. Studies to clarify the role of nitric oxide on FMD have been done with various methods, which require extensive training and standardization. Operator, study preparation, image acquisition and site selection, sphygmomanometer probe position, cuff occlusion time, the accurate use of edge-detection software as well as the correct characterization of the FMD response are all factors, which influence FMD measurement.
In this study the goal is to analyze in a clinical trial to what extent nitric oxide contribute to FMD by measuring FMD before and after blocking the release of nitric oxide. FMD is measured using a semi-automatic device named UNEX, recently developed in Japan. FMD measurements using UNEX implement the standards described in guidelines. This semi-automatic ultrasound system using an H-type ultrasound probe represents a new development that overcomes the limitation of classic systems (in particular the investigator-dependency of conventional, "hand-held" FMD measurements). This system comprised a 7.5-megahertz linear array transducer and a novel stereotactic probe-holding device (UNEX Co., Nagoya, Japan). Another advantage of this device is the continuous recording of B-mode images and A-mode waves of the artery in the longitudinal plane, so that continuous measurement of arterial diameter in the 4.5 min following cuff deflation occurs. A meta-analysis described that the nitric oxide dependency of the FMD response was the most in studies with FMD measurements at brachial artery with distal placement of the cuff and 5-minute occlusion. These criteria are fulfilled by UNEX. However, no data on nitric oxide dependency are available in the literature. Finally, this semi-automatic assessment of FMD has been shown to improve the precision and repeatability of the measurements.
The hypothesis of this study is that FMD response is mostly nitric oxide dependent and this could not be proven so far due to less sensitive conventional tool of FMD measurement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | –Young, male and healthy volunteers without any significant disease |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Young, male and healthy volunteers without any significant disease * Age of 18 and 45 years old
Key inclusion criteria (3 listed)
- Young, male and healthy volunteers without any significant disease
- Age of 18 and 45 years old
- Informed consent has to be given in written form
Key exclusion criteria (8 listed)
- Uncontrolled hypertension or blood pressure >160/100 mmHg
- Known Diabetes mellitus or fasting plasma glucose >126mg/dl
- Subjects having any chronic treatment
- Drug or alcohol abuse
- Allergies or intolerance against the substances used in the study
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
Percent change of flow mediated dilation
Time frame: 1 week after study inclusion
Percent change of flow mediated dilation (UNEX EF) in Response to L-NMMA/Saline infusion
Percent change of flow mediated dilation
Time frame: 2 weeks after study inclusion
Percent change of flow mediated dilation (UNEX EF) in Response to L-NMMA/Saline infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
- Background: PubMed 8822980Makimattila S, Virkamaki A, Groop PH, Cockcroft J, Utriainen T, Fagerudd J, Yki-Jarvinen H. Chronic hyperglycemia impairs endothelial function and insulin sensitivity via different mechanisms in insulin-dependent diabetes mellitus. Circulation. 1996 Sep 15;94(6):1276-82. doi: 10.1161/01.cir.94.6.1276.
- Background: PubMed 2355955Panza JA, Quyyumi AA, Brush JE Jr, Epstein SE. Abnormal endothelium-dependent vascular relaxation in patients with essential hypertension. N Engl J Med. 1990 Jul 5;323(1):22-7. doi: 10.1056/NEJM199007053230105.
- Background: PubMed 1359209Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.
- Background: PubMed 7594037Anderson TJ, Uehata A, Gerhard MD, Meredith IT, Knab S, Delagrange D, Lieberman EH, Ganz P, Creager MA, Yeung AC, et al. Close relation of endothelial function in the human coronary and peripheral circulations. J Am Coll Cardiol. 1995 Nov 1;26(5):1235-41. doi: 10.1016/0735-1097(95)00327-4.
- Background: PubMed 17452608Yeboah J, Crouse JR, Hsu FC, Burke GL, Herrington DM. Brachial flow-mediated dilation predicts incident cardiovascular events in older adults: the Cardiovascular Health Study. Circulation. 2007 May 8;115(18):2390-7. doi: 10.1161/CIRCULATIONAHA.106.678276. Epub 2007 Apr 23.
- Background: PubMed 9069525Neunteufl T, Katzenschlager R, Hassan A, Klaar U, Schwarzacher S, Glogar D, Bauer P, Weidinger F. Systemic endothelial dysfunction is related to the extent and severity of coronary artery disease. Atherosclerosis. 1997 Feb 28;129(1):111-8. doi: 10.1016/s0021-9150(96)06018-2.
- Background: PubMed 21778256Ades PA, Savage PD, Lischke S, Toth MJ, Harvey-Berino J, Bunn JY, Ludlow M, Schneider DJ. The effect of weight loss and exercise training on flow-mediated dilatation in coronary heart disease: a randomized trial. Chest. 2011 Dec;140(6):1420-1427. doi: 10.1378/chest.10-3289. Epub 2011 Jul 21.
- Background: PubMed 7867167Joannides R, Haefeli WE, Linder L, Richard V, Bakkali EH, Thuillez C, Luscher TF. Nitric oxide is responsible for flow-dependent dilatation of human peripheral conduit arteries in vivo. Circulation. 1995 Mar 1;91(5):1314-9. doi: 10.1161/01.cir.91.5.1314.
- Background: PubMed 24277765Green DJ, Dawson EA, Groenewoud HM, Jones H, Thijssen DH. Is flow-mediated dilation nitric oxide mediated?: A meta-analysis. Hypertension. 2014 Feb;63(2):376-82. doi: 10.1161/HYPERTENSIONAHA.113.02044. Epub 2013 Nov 25.
- Background: PubMed 23595043Iguchi T, Takemoto Y, Shimada K, Matsumoto K, Nakanishi K, Otsuka K, Hyodo E, Hirohashi K, Tahara A, Yoshiyama M. Simultaneous assessment of endothelial function and morphology in the brachial artery using a new semiautomatic ultrasound system. Hypertens Res. 2013 Aug;36(8):691-7. doi: 10.1038/hr.2013.35. Epub 2013 Apr 18.
- Background: PubMed 26291496Tomiyama H, Kohro T, Higashi Y, Takase B, Suzuki T, Ishizu T, Ueda S, Yamazaki T, Furumoto T, Kario K, Inoue T, Koba S, Watanabe K, Takemoto Y, Hano T, Sata M, Ishibashi Y, Node K, Maemura K, Ohya Y, Furukawa T, Ito H, Ikeda H, Yamashina A. Reliability of measurement of endothelial function across multiple institutions and establishment of reference values in Japanese. Atherosclerosis. 2015 Oct;242(2):433-42. doi: 10.1016/j.atherosclerosis.2015.08.001. Epub 2015 Aug 5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 FMD - Flow Mediated Dilation, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 3 inclusion and 8 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 18 Feb 2020. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent change of flow mediated dilation (time frame: 1 week after study inclusion). 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 NCT03723278, which also lists 11 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 Feb 2020.