Pulmonary HypertensionNCT05256082
Impact of Face Masks on 6MWD in Patients With Pulmonary Hypertension
A study testing six-minutes-walking test in people with Pulmonary Hypertension, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
Pulmonary hypertension (PH) is classified according to the Nice Classification into different etiologies, including pulmonary arterial hypertension (PAH), a disease of the pulmonary arteriolar vasculature (Class I), and forms of pulmonary hypertension associated with left heart disease (Class II), lung disease (Class… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- six-minutes-walking test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteGermany
- Study dates
- 15 Nov 2020to 31 Mar 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regular 6MWD in the last 24 months, at least 1 test per 24 months
- Pulmonary (arterial) hypertension according to the Nice Classification Type I-V
- NYHA-WHO/FC I - III
- Lung function test performed within 6 months
- Age ≥18 years
- Severity of symptoms and specific therapy stable during the last 4 weeks
- General ability to participate in the study
- Ability to give consent
Who cannot join
- Contact allergy to face mask materials
- Significant peripheral arterial occlusive disease (Fontaine ≥ IIb)
- Muscular or orthopedic diseases of the lower extremities that contribute to reduced resilience
- Relevant coronary heart disease (angina pectoris ≥ CCS II or positive stress test, myocardial infarction or bypass surgery within the last 3 months)
- inability to perform the 6-minute walk test (mental, physical) or lack of ability to provide essential information (questionnaire, Borg level)
- Uncontrolled high blood pressure (≥140/90 mmHg or ≥160/100 mmHg with 3 antihypertensive drugs) or resting heart rate ≥ 100 b.p.m.)
- Fresh fractures / broken bones (within the last 3 months)
- Not able to give consent Insufficient ability to walk (NYHA IV, immobility, other ailments)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Face Masks on the Six Minute Walking Distance in Pulmonary Hypertension Patients During the COVID-19 Pandemic: A Prospective, Randomized Cross-over Study
Pulmonary hypertension (PH) is classified according to the Nice Classification into different etiologies, including pulmonary arterial hypertension (PAH), a disease of the pulmonary arteriolar vasculature (Class I), and forms of pulmonary hypertension associated with left heart disease (Class II), lung disease (Class III), pulmonary artery obstructions including chronic pulmonary embolism (Class IV) or other less common causes (Class V). Patients with PH are at risk in the current COVID 19 pandemic.
The course of the disease and the prognosis of the patients are assessed on the basis of various parameters and therapy is adapted accordingly. In addition to clinical, echocardiographic and laboratory examinations, cardiopulmonary performance tests such as the 6-minute walking distance (6MWD) are of particular significance. According to the ESC/ERS guidelines for PH and the recommendations of the Cologne Consensus Conference, exercise performance is a central criterion for prognostication and treatment decisions.
During the COVID-19 pandemic, hospitals require the constant use of face masks for patients, in most cases also during the 6 minute walking test. We suspect a performance-reducing effect of face masks, thus impacting the results of the 6MWD. A systematic error in the assessment of cardiopulmonary performance should be revealed by comparing the results of the 6MWD with and without mask (particularly surgical mask and FFP2 mask).
Read the detailed description
Monocentric, prospective, randomized cross-over study in approximately 120 patients with PH (n=60 for surgical face mask versus no mask; n=60 for FFP2 mask vs. no mask) to evaluate the impact of face masks on 6MWD, Borg dyspnea score, and O2 saturation pre- versus post exercise. Patients are randomized to perform the test with vs. without mask first, and then cross over to the respective other condition.
The primary endpoint is the intra-individual difference in 6MWD with and without mask (analyzed for the whole study group, and for surgical mask and FFP2 mask seperately). Secondary endpoints include differences in Borg score, and O2 saturation.
- Conditions
- Pulmonary Hypertension
- Being tested
- six-minutes-walking test
- Keywords
- pulmonary hypertension, exercise capacity, six minute walking distance, face mask, COVID-19
- Medical subject headings
- Hypertension, Pulmonary, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
six-minutes-walking testDiagnostic test
Patients conducting a six-minutes-walking test
| Study group | Role | What they receive |
|---|---|---|
| with mask (FFP2 mask or surgical mask) | Active comparator | Patient is Walking with mouth/nose-mask for 6 Minutes. Receives: Diagnostic Test: six-minutes-walking test |
| without mask | Placebo comparator | Patient is Walking without mouth/nose-mask for 6 Minutes. Receives: Diagnostic Test: six-minutes-walking test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-individual difference in six-minute-walking-distance (6MWD) with versus without face mask
Patients repeat a walking-test, conducting 2 walks on one day while a Follow-Up-visit. Change in six-minutes-walking-distance will be measured intra-individually. Patients are walking without mask (control) and wearing a mask (intervention). Minimum 1 hour of rest in between control and intervention. A cross-over design is performed with randomization, if mask will be used in the first six-minutes-walking.
Measured: one day while follow-up visit in PAH-center
Secondary outcomes (5)
PAH-specific Quality of life Baseline
PAH-specific Quality of life assessed by PAH-Sympact (Pulmonary Arterial Hypertension-Symptoms and Impact Questionnaire)
Measured: while follow-up 1 day visit in PAH-center
Depression Baseline
Depression assessed by PHQ9 (Patient Health Questionnaire, 1-27 points with higher depression-severity with higher total points)
Measured: while follow-up 1 day visit in PAH-center
Anxiety Baseline
Anxiety assessed by GAD7 (Generalized Anxiety Disorder Scale 7; 0-21 points with higher Anxiety-Symptoms with higher total points)
Measured: while follow-up 1 day visit in PAH-center
Intra-individual difference in pSO2 performing a six-minutes-walking-test (6MWT) with face mask
Patients repeat a walking-test, conducting 2 walks on one day while a Follow-Up-visit. Change in pSO2 while the six-minutes-walking-test will be measured intra-individually. Patients are walking without mask (control) and wearing a mask (intervention). Minimum 1 hour of rest in between control and intervention. A cross-over design is performed with randomization, if mask will be used in the first six-minutes-walking.
The pSO2 is continuously documented while patients perform the walking test and while the first 3 Minutes of rest after walking.
Measured: one day while follow-up-visit in PAH-center
Intra-individual difference in Borg dyspnea score after a six-minutes-walking-test (6MWT) with versus without face mask
Patients repeat a walking-test, conducting 2 walks on one day while a Follow-Up-visit. Dyspnea is assessed by Borg dyspnea score (Borg dyspnea score; 0-10 points with increasing dyspnea-severity with higher total points)
Measured: one day while follow-up-visit in PAH-center
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start15 Nov 2020
- Primary completion2 Feb 2022
- Study completion31 Mar 2022
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 Pulmonary 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Wissmueller, University Hospital of Cologne
- Investigators
- Max VJ Wissmueller, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256082
- Sponsor's protocol ID
- 2020_01
- Other IDs
- UoC Ethics 20-1581-1
- Status last verified
- Jul 2022
- First submitted
- 4 Nov 2020
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tschope C, Birner C, Bohm M, Bruder O, Frantz S, Luchner A, Maier L, Stork S, Kherad B, Laufs U. Heart failure with preserved ejection fraction: current management and future strategies : Expert opinion on the behalf of the Nucleus of the "Heart Failure Working Group" of the German Society of Cardiology (DKG). Clin Res Cardiol. 2018 Jan;107(1):1-19. doi: 10.1007/s00392-017-1170-6. Epub 2017 Oct 10.
PubMed 29018938Eikenberry SE, Mancuso M, Iboi E, Phan T, Eikenberry K, Kuang Y, Kostelich E, Gumel AB. To mask or not to mask: Modeling the potential for face mask use by the general public to curtail the COVID-19 pandemic. Infect Dis Model. 2020 Apr 21;5:293-308. doi: 10.1016/j.idm.2020.04.001. eCollection 2020.
PubMed 32355904Greenhalgh T, Schmid MB, Czypionka T, Bassler D, Gruer L. Face masks for the public during the covid-19 crisis. BMJ. 2020 Apr 9;369:m1435. doi: 10.1136/bmj.m1435. No abstract available.
PubMed 32273267Liang M, Gao L, Cheng C, Zhou Q, Uy JP, Heiner K, Sun C. Efficacy of face mask in preventing respiratory virus transmission: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Jul-Aug;36:101751. doi: 10.1016/j.tmaid.2020.101751. Epub 2020 May 28.
PubMed 32473312Lyu W, Wehby GL. Community Use Of Face Masks And COVID-19: Evidence From A Natural Experiment Of State Mandates In The US. Health Aff (Millwood). 2020 Aug;39(8):1419-1425. doi: 10.1377/hlthaff.2020.00818. Epub 2020 Jun 16.
PubMed 32543923Worby CJ, Chang HH. Face mask use in the general population and optimal resource allocation during the COVID-19 pandemic. Nat Commun. 2020 Aug 13;11(1):4049. doi: 10.1038/s41467-020-17922-x.
PubMed 32792562Roberge RJ, Kim JH, Benson SM. Absence of consequential changes in physiological, thermal and subjective responses from wearing a surgical mask. Respir Physiol Neurobiol. 2012 Apr 15;181(1):29-35. doi: 10.1016/j.resp.2012.01.010. Epub 2012 Feb 2.
PubMed 22326638Roberge RJ, Coca A, Williams WJ, Palmiero AJ, Powell JB. Surgical mask placement over N95 filtering facepiece respirators: physiological effects on healthcare workers. Respirology. 2010 Apr;15(3):516-21. doi: 10.1111/j.1440-1843.2010.01713.x. Epub 2010 Mar 11.
PubMed 20337987Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science. 2020 May 1;368(6490):489-493. doi: 10.1126/science.abb3221. Epub 2020 Mar 16.
PubMed 32179701Fikenzer S, Laufs U. Response to Letter to the editors referring to Fikenzer, S., Uhe, T., Lavall, D., Rudolph, U., Falz, R., Busse, M., Hepp, P., & Laufs, U. (2020). Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clinical research in cardiology: official journal of the German Cardiac Society, 1-9. Advance online publication. https://doi.org/10.1007/s00392-020-01704-y. Clin Res Cardiol. 2020 Dec;109(12):1600. doi: 10.1007/s00392-020-01736-4. Epub 2020 Sep 23. No abstract available.
PubMed 32989474Wissmuller M, Wartner V, Hohmann C, Adler J, Kramer T, Hellmich M, Gerhardt F, Baldus S, Rosenkranz S. Impact of face masks on the 6-minute walk distance in pulmonary hypertension patients during the COVID-19 pandemic: a prospective, randomised cross-over study. Eur Respir J. 2023 Oct 26;62(4):2201454. doi: 10.1183/13993003.01454-2022. Print 2023 Oct.
PubMed 37827573
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Face Masks on the Six Minute Walking Distance in Pulmonary Hypertension Patients During the COVID-19 Pandemic: A Prospective, Randomized Cross-over Study
- ClinicalTrials.gov ID
- NCT05256082
- Acronym / sponsor ID
- 2020_01
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, exercise capacity, six minute walking distance, face mask, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 2 Feb 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 25 Feb 2022 (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.
Pulmonary hypertension (PH) is classified according to the Nice Classification into different etiologies, including pulmonary arterial hypertension (PAH), a disease of the pulmonary arteriolar vasculature (Class I), and forms of pulmonary hypertension associated with left heart disease (Class II), lung disease (Class III), pulmonary artery obstructions including chronic pulmonary embolism (Class IV) or other less common causes (Class V). Patients with PH are at risk in the current COVID 19 pandemic.
The course of the disease and the prognosis of the patients are assessed on the basis of various parameters and therapy is adapted accordingly. In addition to clinical, echocardiographic and laboratory examinations, cardiopulmonary performance tests such as the 6-minute walking distance (6MWD) are of particular significance. According to the ESC/ERS guidelines for PH and the recommendations of the Cologne Consensus Conference, exercise performance is a central criterion for prognostication and treatment decisions.
During the COVID-19 pandemic, hospitals require the constant use of face masks for patients, in most cases also during the 6 minute walking test. We suspect a performance-reducing effect of face masks, thus impacting the results of the 6MWD. A systematic error in the assessment of cardiopulmonary performance should be revealed by comparing the results of the 6MWD with and without mask (particularly surgical mask and FFP2 mask).
Detailed description
Monocentric, prospective, randomized cross-over study in approximately 120 patients with PH (n=60 for surgical face mask versus no mask; n=60 for FFP2 mask vs. no mask) to evaluate the impact of face masks on 6MWD, Borg dyspnea score, and O2 saturation pre- versus post exercise. Patients are randomized to perform the test with vs. without mask first, and then cross over to the respective other condition.
The primary endpoint is the intra-individual difference in 6MWD with and without mask (analyzed for the whole study group, and for surgical mask and FFP2 mask seperately). Secondary endpoints include differences in Borg score, and O2 saturation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with mask (FFP2 mask or surgical mask) | Active comparator | Diagnostic Test: six-minutes-walking testPatient is Walking with mouth/nose-mask for 6 Minutes. |
| without mask | Placebo comparator | Diagnostic Test: six-minutes-walking testPatient is Walking without mouth/nose-mask for 6 Minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Regular 6MWD in the last 24 months, at least 1 test per 24 months
- Pulmonary (arterial) hypertension according to the Nice Classification Type I-V
- NYHA-WHO/FC I - III
- Lung function test performed within 6 months
- Age ≥18 years
Key exclusion criteria (8 listed)
- Contact allergy to face mask materials
- Significant peripheral arterial occlusive disease (Fontaine ≥ IIb)
- Muscular or orthopedic diseases of the lower extremities that contribute to reduced resilience
- Relevant coronary heart disease (angina pectoris ≥ CCS II or positive stress test, myocardial infarction or bypass surgery within the last 3 months)
- inability to perform the 6-minute walk test (mental, physical) or lack of ability to provide essential information (questionnaire, Borg level)
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 |
|---|---|---|
| six-minutes-walking testPatients conducting a six-minutes-walking test | Diagnostic test | with mask (FFP2 mask or surgical mask), without mask |
Primary outcome
Intra-individual difference in six-minute-walking-distance (6MWD) with versus without face mask
Time frame: one day while follow-up visit in PAH-center
Patients repeat a walking-test, conducting 2 walks on one day while a Follow-Up-visit. Change in six-minutes-walking-distance will be measured intra-individually. Patients are walking without mask (control) and wearing a mask (intervention). Minimum 1 hour of rest in between control and intervention. A cross-over design is performed with randomization, if mask will be used in the first six-minutes-walking.
5 secondary outcomes
PAH-specific Quality of life Baseline
Time frame: while follow-up 1 day visit in PAH-center
Depression Baseline
Time frame: while follow-up 1 day visit in PAH-center
Anxiety Baseline
Time frame: while follow-up 1 day visit in PAH-center
Intra-individual difference in pSO2 performing a six-minutes-walking-test (6MWT) with face mask
Time frame: one day while follow-up-visit in PAH-center
Intra-individual difference in Borg dyspnea score after a six-minutes-walking-test (6MWT) with versus without face mask
Time frame: one day while follow-up-visit in PAH-center
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 21 Jul 2022.
- Background: PubMed 29018938Tschope C, Birner C, Bohm M, Bruder O, Frantz S, Luchner A, Maier L, Stork S, Kherad B, Laufs U. Heart failure with preserved ejection fraction: current management and future strategies : Expert opinion on the behalf of the Nucleus of the "Heart Failure Working Group" of the German Society of Cardiology (DKG). Clin Res Cardiol. 2018 Jan;107(1):1-19. doi: 10.1007/s00392-017-1170-6. Epub 2017 Oct 10.
- Background: PubMed 32355904Eikenberry SE, Mancuso M, Iboi E, Phan T, Eikenberry K, Kuang Y, Kostelich E, Gumel AB. To mask or not to mask: Modeling the potential for face mask use by the general public to curtail the COVID-19 pandemic. Infect Dis Model. 2020 Apr 21;5:293-308. doi: 10.1016/j.idm.2020.04.001. eCollection 2020.
- Background: PubMed 32273267Greenhalgh T, Schmid MB, Czypionka T, Bassler D, Gruer L. Face masks for the public during the covid-19 crisis. BMJ. 2020 Apr 9;369:m1435. doi: 10.1136/bmj.m1435. No abstract available.
- Background: PubMed 32473312Liang M, Gao L, Cheng C, Zhou Q, Uy JP, Heiner K, Sun C. Efficacy of face mask in preventing respiratory virus transmission: A systematic review and meta-analysis. Travel Med Infect Dis. 2020 Jul-Aug;36:101751. doi: 10.1016/j.tmaid.2020.101751. Epub 2020 May 28.
- Background: PubMed 32543923Lyu W, Wehby GL. Community Use Of Face Masks And COVID-19: Evidence From A Natural Experiment Of State Mandates In The US. Health Aff (Millwood). 2020 Aug;39(8):1419-1425. doi: 10.1377/hlthaff.2020.00818. Epub 2020 Jun 16.
- Background: PubMed 32792562Worby CJ, Chang HH. Face mask use in the general population and optimal resource allocation during the COVID-19 pandemic. Nat Commun. 2020 Aug 13;11(1):4049. doi: 10.1038/s41467-020-17922-x.
- Background: PubMed 22326638Roberge RJ, Kim JH, Benson SM. Absence of consequential changes in physiological, thermal and subjective responses from wearing a surgical mask. Respir Physiol Neurobiol. 2012 Apr 15;181(1):29-35. doi: 10.1016/j.resp.2012.01.010. Epub 2012 Feb 2.
- Background: PubMed 20337987Roberge RJ, Coca A, Williams WJ, Palmiero AJ, Powell JB. Surgical mask placement over N95 filtering facepiece respirators: physiological effects on healthcare workers. Respirology. 2010 Apr;15(3):516-21. doi: 10.1111/j.1440-1843.2010.01713.x. Epub 2010 Mar 11.
- Background: PubMed 32179701Li R, Pei S, Chen B, Song Y, Zhang T, Yang W, Shaman J. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-CoV-2). Science. 2020 May 1;368(6490):489-493. doi: 10.1126/science.abb3221. Epub 2020 Mar 16.
- Background: PubMed 32989474Fikenzer S, Laufs U. Response to Letter to the editors referring to Fikenzer, S., Uhe, T., Lavall, D., Rudolph, U., Falz, R., Busse, M., Hepp, P., & Laufs, U. (2020). Effects of surgical and FFP2/N95 face masks on cardiopulmonary exercise capacity. Clinical research in cardiology: official journal of the German Cardiac Society, 1-9. Advance online publication. https://doi.org/10.1007/s00392-020-01704-y. Clin Res Cardiol. 2020 Dec;109(12):1600. doi: 10.1007/s00392-020-01736-4. Epub 2020 Sep 23. No abstract available.
- Derived from this study: PubMed 37827573Wissmuller M, Wartner V, Hohmann C, Adler J, Kramer T, Hellmich M, Gerhardt F, Baldus S, Rosenkranz S. Impact of face masks on the 6-minute walk distance in pulmonary hypertension patients during the COVID-19 pandemic: a prospective, randomised cross-over study. Eur Respir J. 2023 Oct 26;62(4):2201454. doi: 10.1183/13993003.01454-2022. Print 2023 Oct.
- 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.
Max VJ Wissmueller, MD principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing six-minutes-walking test in people with Pulmonary Hypertension, run by University Hospital of Cologne 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 8 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 21 Jul 2022. 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. Some participants in this study may receive a placebo. 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?
Intra-individual difference in six-minute-walking-distance (6MWD) with versus without face mask (time frame: one day while follow-up visit in PAH-center). 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 NCT05256082, 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 21 Jul 2022.