HypertensionNCT03147573
Validity of 1BPM for Diagnosis of Hypertension
A study testing 1-hour blood pressure monitoring (1BPM), 24-hour ambulatory blood pressure monitoring (ABPM) and Office blood pressure measurement (OBPM) in people with Hypertension, run by Consorci d'Atenció Primària de Salut de l'Eixample at 3 sites in Spain.
Trial summary
Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- 1-hour blood pressure monitoring (1BPM), 24-hour ambulatory blood pressure monitoring (ABPM) and Office blood pressure measurement (OBPM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jun 2017to 30 Sep 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years
- To visit routinely in the health centres where the study is carried out
Who cannot join
- Severe physical or cognitive limitations
- Atrial fibrillation or other heart rhythm disorders that could interfere with readings
- Arm Circumference > 42cm
- Arm with arteriovenous fistula
- Mental disorders
- Intolerance to the method of measurement
- Hospitalization during the study period
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Primary Care Center Les Corts
Barcelona, Catalonia, 08028
Primary Care Center Casanova
Barcelona, Catalonia, 08036
Primary Care Center Comte Borrell
Barcelona, Catalonia, 08036
About this study
Official title: Validity of 1-hour Blood Pressure Monitoring Against the Usual Methods for Diagnosis of Hypertension
Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. A recent British guideline recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these devices are not available at all health centers and they can only be used by one patient per day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM), to diagnose the hypertension.
Participants with suspected hypertension will be recruited from a population of patients seen at three primary health centers in an urban area. According to the sample size estimation, a minimum sample size of 214 participants would be needed for the study. Four diagnostic tests will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be compared to all other monitoring methods using the correlation coefficients and Bland Altman plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and specificity of the methods will also be calculated.
- Conditions
- Hypertension
- Being tested
- 1-hour blood pressure monitoring (1BPM), 24-hour ambulatory blood pressure monitoring (ABPM), Office blood pressure measurement (OBPM), Home blood pressure monitoring (HBPM)
- Keywords
- Hypertension, Blood pressure monitoring
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-hour blood pressure monitoring (1BPM)Diagnostic test
This method consists of performing blood pressure measurements programmed at 5-min intervals over 1 hour. Two extra recordings taken at the start and end of this period are discarded. Blood pressure is measured in a quiet room at the same health centre.
24-hour ambulatory blood pressure monitoring (ABPM)Diagnostic test
The device is programmed to record the participant's BP every 20 min and 30 min during the day and night, respectively. Participants are advised to carry on with their normal daily activities, avoiding any intense physical exertion, and to remain at rest when their BP is being measured.
Office blood pressure measurement (OBPM)Diagnostic test
Two readings were made one minute apart with a validated automatic sphygmomanometer in a sitting position after five minutes of rest. The average of two readings is calculated. The procedure is repeated during 3 office visits at least a week apart.
Home blood pressure monitoring (HBPM)Diagnostic test
For each blood pressure recording, at least two consecutive measurements should be taken, at least one minute apart. Blood pressure should be recorded twice daily, ideally in the morning and evening. Blood pressure recording should continue for at least four consecutive days, ideally seven. The average of the above readings should be calculated, ignoring the first day.
| Study group | Role | What they receive |
|---|---|---|
| Blood pressure monitoring | Experimental | Not described Receives: Diagnostic Test: 1-hour blood pressure monitoring (1BPM); Diagnostic Test: 24-hour ambulatory blood pressure monitoring (ABPM); Diagnostic Test: Office blood pressure measurement (OBPM); Diagnostic Test: Home blood pressure monitoring (HBPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-hour blood pressure monitoring
Blood pressure measurements obtained by 1-hour blood pressure monitoring
Measured: Assessed at 1 study visit (1 hour)
24-hour ambulatory blood pressure monitoring
Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring
Measured: Assessed at 1 day
Office blood pressure measurement
Blood pressure measurements obtained by office blood pressure measurement
Measured: Assessed at 3 study visits in two weeks
Home blood pressure monitoring
Blood pressure measurements obtained by home blood pressure monitoring
Measured: Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Jun 2017
- Primary completion30 Jul 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci d'Atenció Primària de Salut de l'Eixample
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Dr. Antoni Siso Almirall, Consorci d'Atenció Primària de Salut de l'Eixample
- Investigators
- Antoni Sisó Almirall, MD PhD, Principal investigator, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)Luis González de Paz, PhD, Study chair, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)Belchin Kostov, PhD, Study chair, Transversal Group for Research in Primary Care, IDIBAPSCristina Sierra Benito, MD PhD, Study chair, Hospital Clinic of BarcelonaJosep Miquel Sotoca, PhD, Study chair, Hospital Clinic of BarcelonaMª Carme Alvira, RN, Study chair, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)Cristina Colungo, RN, Study chair, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)Berta de Andrés, RN, Study chair, Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147573
- Sponsor's protocol ID
- PI16/00660
- Status last verified
- Feb 2020
- First submitted
- 2 May 2017
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banegas JR, Graciani A, de la Cruz-Troca JJ, Leon-Munoz LM, Guallar-Castillon P, Coca A, Ruilope LM, Rodriguez-Artalejo F. Achievement of cardiometabolic goals in aware hypertensive patients in Spain: a nationwide population-based study. Hypertension. 2012 Oct;60(4):898-905. doi: 10.1161/HYPERTENSIONAHA.112.193078. Epub 2012 Sep 4.
PubMed 22949530Yang Q, Cogswell ME, Flanders WD, Hong Y, Zhang Z, Loustalot F, Gillespie C, Merritt R, Hu FB. Trends in cardiovascular health metrics and associations with all-cause and CVD mortality among US adults. JAMA. 2012 Mar 28;307(12):1273-83. doi: 10.1001/jama.2012.339. Epub 2012 Mar 16.
PubMed 22427615Sicras-Mainar A, Navarro-Artieda R. [Cost of arterial hypertension according to levels of morbidity in primary care setting]. Med Clin (Barc). 2009 Sep 5;133(8):290-5. doi: 10.1016/j.medcli.2009.05.017. Epub 2009 Jul 10. Spanish.
PubMed 19596366ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013 Oct;31(10):1925-38. doi: 10.1097/HJH.0b013e328364ca4c. No abstract available.
PubMed 24107724Piper MA, Evans CV, Burda BU, Margolis KL, O'Connor E, Whitlock EP. Diagnostic and predictive accuracy of blood pressure screening methods with consideration of rescreening intervals: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2015 Feb 3;162(3):192-204. doi: 10.7326/M14-1539.
PubMed 25531400Krause T, Lovibond K, Caulfield M, McCormack T, Williams B; Guideline Development Group. Management of hypertension: summary of NICE guidance. BMJ. 2011 Aug 25;343:d4891. doi: 10.1136/bmj.d4891. No abstract available.
PubMed 21868454Siu AL; U.S. Preventive Services Task Force. Screening for high blood pressure in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015 Nov 17;163(10):778-86. doi: 10.7326/M15-2223. Epub 2015 Oct 13.
PubMed 26458123Turner JR, Viera AJ, Shimbo D. Ambulatory blood pressure monitoring in clinical practice: a review. Am J Med. 2015 Jan;128(1):14-20. doi: 10.1016/j.amjmed.2014.07.021. Epub 2014 Aug 12.
PubMed 25107387Chrubasik S, Droste C, Glimm E, Black A. Comparison of different methods of blood pressure measurements. Blood Press Monit. 2007 Jun;12(3):157-66. doi: 10.1097/MBP.0b013e3280ad4073.
PubMed 17496465Mutlu S, Sari O, Arslan E, Aydogan U, Doganer YC, Koc B. Comparison of ambulatory blood pressure measurement with home, office and pharmacy measurements: is arterial blood pressure measured at pharmacy reliable? J Eval Clin Pract. 2016 Feb;22(1):40-45. doi: 10.1111/jep.12424. Epub 2015 Aug 24.
PubMed 26303331Gaborieau V, Delarche N, Gosse P. Ambulatory blood pressure monitoring versus self-measurement of blood pressure at home: correlation with target organ damage. J Hypertens. 2008 Oct;26(10):1919-27. doi: 10.1097/HJH.0b013e32830c4368.
PubMed 18806615Viera AJ, Hinderliter AL, Kshirsagar AV, Fine J, Dominik R. Reproducibility of masked hypertension in adults with untreated borderline office blood pressure: comparison of ambulatory and home monitoring. Am J Hypertens. 2010 Nov;23(11):1190-7. doi: 10.1038/ajh.2010.158. Epub 2010 Jul 29.
PubMed 20671718Banegas JR, Segura J, Sobrino J, Rodriguez-Artalejo F, de la Sierra A, de la Cruz JJ, Gorostidi M, Sarria A, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Effectiveness of blood pressure control outside the medical setting. Hypertension. 2007 Jan;49(1):62-8. doi: 10.1161/01.HYP.0000250557.63490.55. Epub 2006 Oct 30.
PubMed 17075026Little P, Barnett J, Barnsley L, Marjoram J, Fitzgerald-Barron A, Mant D. Comparison of agreement between different measures of blood pressure in primary care and daytime ambulatory blood pressure. BMJ. 2002 Aug 3;325(7358):254. doi: 10.1136/bmj.325.7358.254.
PubMed 12153923Gorostidi M, Banegas JR, de la Sierra A, Vinyoles E, Segura J, Ruilope LM. Ambulatory blood pressure monitoring in daily clinical practice - the Spanish ABPM Registry experience. Eur J Clin Invest. 2016 Jan;46(1):92-8. doi: 10.1111/eci.12565. Epub 2015 Dec 23.
PubMed 26541761
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of 1-hour Blood Pressure Monitoring Against the Usual Methods for Diagnosis of Hypertension
- ClinicalTrials.gov ID
- NCT03147573
- Acronym / sponsor ID
- PI16/00660
- Conditions
- Hypertension
- Keywords
- Hypertension, Blood pressure monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Consorci d'Atenció Primària de Salut de l'EixampleUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 10 May 2017 (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.
Blood pressure measurement methods and conditions are determinants of hypertension diagnosis. The classical methods such as office blood pressure measurement (OBPM) and home blood pressure monitoring (HBPM) have significant limitations. A recent British guideline recommends systematic 24-hour ambulatory blood pressure monitoring (ABPM). However, these devices are not available at all health centers and they can only be used by one patient per day. The aim this study is to validate a new method, 1-hour blood pressure monitoring (1BPM), to diagnose the hypertension.
Participants with suspected hypertension will be recruited from a population of patients seen at three primary health centers in an urban area. According to the sample size estimation, a minimum sample size of 214 participants would be needed for the study. Four diagnostic tests will be performed: OBPM at three visits, HBPM, AMPM and 1BPM. The test order for the 24-hour monitoring, and 1-hour monitoring, will be set randomly. Daytime records of ABPM will be compared to all other monitoring methods using the correlation coefficients and Bland Altman plots. The Kappa index will be used to calculate degree of agreement. The sensitivity and specificity of the methods will also be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood pressure monitoring | Experimental | Diagnostic Test: 1-hour blood pressure monitoring (1BPM), Diagnostic Test: 24-hour ambulatory blood pressure monitoring (ABPM), Diagnostic Test: Office blood pressure measurement (OBPM), Diagnostic Test: Home blood pressure monitoring (HBPM) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- To visit routinely in the health centres where the study is carried out
Key exclusion criteria (7 listed)
- Severe physical or cognitive limitations
- Atrial fibrillation or other heart rhythm disorders that could interfere with readings
- Arm Circumference > 42cm
- Arm with arteriovenous fistula
- Mental disorders
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 |
|---|---|---|
| 1-hour blood pressure monitoring (1BPM)This method consists of performing blood pressure measurements programmed at 5-min intervals over 1 hour. Two extra recordings taken at the start and end of this period are discarded. Blood pressure is measured in a quiet room at the same health centre. | Diagnostic test | Blood pressure monitoring |
| 24-hour ambulatory blood pressure monitoring (ABPM)The device is programmed to record the participant's BP every 20 min and 30 min during the day and night, respectively. Participants are advised to carry on with their normal daily activities, avoiding any intense physical exertion, and to remain at rest when their BP is being measured. | Diagnostic test | Blood pressure monitoring |
| Office blood pressure measurement (OBPM)Two readings were made one minute apart with a validated automatic sphygmomanometer in a sitting position after five minutes of rest. The average of two readings is calculated. The procedure is repeated during 3 office visits at least a week apart. | Diagnostic test | Blood pressure monitoring |
| Home blood pressure monitoring (HBPM)For each blood pressure recording, at least two consecutive measurements should be taken, at least one minute apart. Blood pressure should be recorded twice daily, ideally in the morning and evening. Blood pressure recording should continue for at least four consecutive days, ideally seven. The average of the above readings should be calculated, ignoring the first day. | Diagnostic test | Blood pressure monitoring |
Primary outcome
1-hour blood pressure monitoring
Time frame: Assessed at 1 study visit (1 hour)
Blood pressure measurements obtained by 1-hour blood pressure monitoring
24-hour ambulatory blood pressure monitoring
Time frame: Assessed at 1 day
Blood pressure measurements obtained by 24-hour ambulatory blood pressure monitoring
Office blood pressure measurement
Time frame: Assessed at 3 study visits in two weeks
Blood pressure measurements obtained by office blood pressure measurement
Home blood pressure monitoring
Time frame: Assessed twice daily, ideally in the morning and evening, during at least four consecutive days, ideally seven
Blood pressure measurements obtained by home blood pressure monitoring
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 2 Mar 2020.
- Background: PubMed 22949530Banegas JR, Graciani A, de la Cruz-Troca JJ, Leon-Munoz LM, Guallar-Castillon P, Coca A, Ruilope LM, Rodriguez-Artalejo F. Achievement of cardiometabolic goals in aware hypertensive patients in Spain: a nationwide population-based study. Hypertension. 2012 Oct;60(4):898-905. doi: 10.1161/HYPERTENSIONAHA.112.193078. Epub 2012 Sep 4.
- Background: PubMed 22427615Yang Q, Cogswell ME, Flanders WD, Hong Y, Zhang Z, Loustalot F, Gillespie C, Merritt R, Hu FB. Trends in cardiovascular health metrics and associations with all-cause and CVD mortality among US adults. JAMA. 2012 Mar 28;307(12):1273-83. doi: 10.1001/jama.2012.339. Epub 2012 Mar 16.
- Background: PubMed 19596366Sicras-Mainar A, Navarro-Artieda R. [Cost of arterial hypertension according to levels of morbidity in primary care setting]. Med Clin (Barc). 2009 Sep 5;133(8):290-5. doi: 10.1016/j.medcli.2009.05.017. Epub 2009 Jul 10. Spanish.
- Background: PubMed 24107724ESH/ESC Task Force for the Management of Arterial Hypertension. 2013 Practice guidelines for the management of arterial hypertension of the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC): ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2013 Oct;31(10):1925-38. doi: 10.1097/HJH.0b013e328364ca4c. No abstract available.
- Background: PubMed 25531400Piper MA, Evans CV, Burda BU, Margolis KL, O'Connor E, Whitlock EP. Diagnostic and predictive accuracy of blood pressure screening methods with consideration of rescreening intervals: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2015 Feb 3;162(3):192-204. doi: 10.7326/M14-1539.
- Background: PubMed 21868454Krause T, Lovibond K, Caulfield M, McCormack T, Williams B; Guideline Development Group. Management of hypertension: summary of NICE guidance. BMJ. 2011 Aug 25;343:d4891. doi: 10.1136/bmj.d4891. No abstract available.
- Background: PubMed 26458123Siu AL; U.S. Preventive Services Task Force. Screening for high blood pressure in adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015 Nov 17;163(10):778-86. doi: 10.7326/M15-2223. Epub 2015 Oct 13.
- Background: PubMed 25107387Turner JR, Viera AJ, Shimbo D. Ambulatory blood pressure monitoring in clinical practice: a review. Am J Med. 2015 Jan;128(1):14-20. doi: 10.1016/j.amjmed.2014.07.021. Epub 2014 Aug 12.
- Background: PubMed 17496465Chrubasik S, Droste C, Glimm E, Black A. Comparison of different methods of blood pressure measurements. Blood Press Monit. 2007 Jun;12(3):157-66. doi: 10.1097/MBP.0b013e3280ad4073.
- Background: PubMed 26303331Mutlu S, Sari O, Arslan E, Aydogan U, Doganer YC, Koc B. Comparison of ambulatory blood pressure measurement with home, office and pharmacy measurements: is arterial blood pressure measured at pharmacy reliable? J Eval Clin Pract. 2016 Feb;22(1):40-45. doi: 10.1111/jep.12424. Epub 2015 Aug 24.
- Background: PubMed 18806615Gaborieau V, Delarche N, Gosse P. Ambulatory blood pressure monitoring versus self-measurement of blood pressure at home: correlation with target organ damage. J Hypertens. 2008 Oct;26(10):1919-27. doi: 10.1097/HJH.0b013e32830c4368.
- Background: PubMed 20671718Viera AJ, Hinderliter AL, Kshirsagar AV, Fine J, Dominik R. Reproducibility of masked hypertension in adults with untreated borderline office blood pressure: comparison of ambulatory and home monitoring. Am J Hypertens. 2010 Nov;23(11):1190-7. doi: 10.1038/ajh.2010.158. Epub 2010 Jul 29.
- 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.
Antoni Sisó Almirall, MD PhD principal investigator
Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
Luis González de Paz, PhD study chair
Consorci d'Atenció Primària de Salut Barcelona Esquerra (CAPSBE)
Belchin Kostov, PhD study chair
Transversal Group for Research in Primary Care, IDIBAPS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1-hour blood pressure monitoring (1BPM), 24-hour ambulatory blood pressure monitoring (ABPM) and Office blood pressure measurement (OBPM) in people with Hypertension, run by Consorci d'Atenció Primària de Salut de l'Eixample at 3 sites in Spain.
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 2 inclusion and 7 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
1-hour blood pressure monitoring (time frame: Assessed at 1 study visit (1 hour)). The study lists 4 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 NCT03147573, which also lists 20 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 2 Mar 2020.