Postural Tachycardia SyndromeNCT03484273
Hemodynamic Effects of Compression in POTS
A study testing LifeWrap Compression Garment in people with Postural Tachycardia Syndrome, run by University of Calgary at 1 site in Canada.
Trial summary
When an individual with Postural Tachycardia Syndrome (POTS) stands up, their heart rate increases significantly (>30BPM) and they may experience symptoms such as lightheadedness, dizziness, shortness of breath, nausea and mental confusion. One commonly prescribed treatment for POTS is compression garments. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postural Tachycardia Syndrome
- What is being tested?
- LifeWrap Compression Garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2018to 26 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physician diagnosis of Postural Tachycardia Syndrome (POTS)
- Age 18-60 years (we are an adult group and we do not see pediatric patients clinically and do not have appropriate pediatric expertise)
- Male and Female
- Able and willing to provide informed consent
- Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Testing Lab at the University of Calgary, Calgary, AB.
Who cannot join
- Overt cause for postural tachycardia, i.e., acute dehydration
- Participants with somatization or severe anxiety symptoms will be excluded (as they may not tolerated study procedures)
- Pregnant women
- Inability to tolerate compression garment for the duration of the study
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Compression in Postural Tachycardia Syndrome (POTS): Effects on Orthostatic Tolerance
When an individual with Postural Tachycardia Syndrome (POTS) stands up, their heart rate increases significantly (>30BPM) and they may experience symptoms such as lightheadedness, dizziness, shortness of breath, nausea and mental confusion.
One commonly prescribed treatment for POTS is compression garments. Compression garments squeeze veins to help return blood back to the heart, which may decrease heart rate and symptoms on standing. However, there is little research about the effectiveness of compression in adults with POTS.
Read more
In this study, the investigators will use the Lifewrap garment, which compresses the abdomen, pelvis and lower extremities, to evaluate the effectiveness of compression in POTS. The investigators will use a head up tilt (HUT) which will simulate standing. The study participant will participate in 4x 10 minute HUTs wearing 4 different compression configurations:
- full abdomen and lower extremity compression
- abdominal only compression
- leg only compression
- No compression
The investigators hypothesize that with full compression, the participant's heart rate increase from lying down to upright will be lower than when they are not wearing any compression. The investigators will also ask the participant about their symptoms when they are upright.
The results of this study could demonstrate the potential benefits of compression and what configuration is most effective. These findings could rapidly translate to the clinical setting, providing improved care.
Read the detailed description
Postural Tachycardia Syndrome (POTS) is a chronic form of orthostatic intolerance marked by a significant and sustained increase in heart rate (HR) upon positional change from supine to standing (>30 beats/min [bpm]) in the absence of orthostatic hypotension (<20/10 mmHg decrease). Symptoms must be present for >6 months and other causes of orthostatic tachycardia must be ruled out. Individuals with POTS report orthostatic symptoms including palpitations, lightheadedness, and mental clouding, which improve on recumbence. The vast majority of individuals diagnosed with POTS are women age 13-50 years.
Upon standing, approximately 500 mL of blood immediately redistributes from the thorax down to the abdomen, buttocks and legs. This leads to sympathetic activation as the baroreceptors sense less pressure. In a healthy individual, HR initially increases 10-20 bpm, and the systolic blood pressure (BP) decreases by approximately 5 mmHg. However, in an individual with POTS, this compensatory mechanism is impaired and HR will increase by >30 bpm and remain at this elevated rate for the duration of standing. In some individuals with POTS, upon standing cerebral blood flow velocity decreases. In other individuals, oscillation of cerebral blood flow due to failure of cerebral autoregulatory mechanisms is observed.
Current treatment of POTS involves pharmacological and non-pharmacological intervention including salt and fluid loading, exercise, and physical countermanuevers. There are no approved medications for use in POTS and all use is off label. Compression garments are also often prescribed. Abdominal/lower extremity compression garments provide pressure to the blood vessels in the legs, thighs and abdomen which can minimize blood pooling and lead to improved blood return to the heart. One such garment is the Lifewrap Non-pneumatic AntiShock garment (NASG), indicated in post-partum hypovolemia.
A pediatric study (n=20) found that orthostatic tachycardia and symptoms were decreased during head up tilt (HUT), with the use of a different NASG compression garment vs. no compression. However, there is no data to validate the efficacy of compression in adults POTS, and also no data to determine which type of compression is most beneficial (e.g. lower leg only, abdomen only, combination).
The investigators hypothesize that the use of the Lifewrap NASG compression garment in a fully applied configuration will decrease orthostatic tachycardia and orthostatic symptoms during a 10 minute HUT vs. no compression garment. The investigators will complete a 4-way randomized crossover study of HUTs with compression applied by the LifeWrap NSAG in at attempt to demonstrate decreased orthostatic tachycardia and increased orthostatic tolerance in individuals with POTS. If successful, this study could provide needed evidence that compression in POTS is a successful non-pharmacological treatment modality, and as well, what type of compression is the most beneficial to patients with this syndrome. These findings could rapidly translate to the clinical setting and improve patient care.
The study participant will complete 4x 10min HUTs during a single study day. There will be 4 compression conditions based on strap configuration of the Lifewrap garment: (1) full abdominal and lower extremity compression, (2) abdominal only compression, (3) lower extremity only compression and (4) no compression. A pressure sensor will used to measure the magnitude of compression pressure applied. The study will be conducted on a tilt table in a human physiology research and procedure room. Each intervention phase in the protocol will involve a supine baseline assessment period of 10 minutes followed by a 10 min HUT (80 degrees). There will be a 20 min recovery periods between each HUT. The study will take approximately 4 hours.
The study participant will be instrumented in a fasting state and on an empty bladder. The investigators will apply skin electrodes to continuously monitor heart rate and record an ECG. BP will be monitored continuously using a finger volume clamp method (Nexfin, Edwards Lifesciences) and calibrated with intermittent brachial cuff measurements (Vital-Guard 450C Patient Care Monitor, IVY Medical). From the continuous BP waveform, the investigators can obtain an estimate of stroke volume, cardiac output, and systemic vascular resistance (Modelflow). Middle cerebral blood flow velocity will be assessed using transcranial doppler.
- Conditions
- Postural Tachycardia Syndrome
- Being tested
- LifeWrap Compression Garment
- Keywords
- Tilt Table, Compression, Dysautonomia, POTS
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeWrap Compression GarmentDevice
Non-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures.
| Study group | Role | What they receive |
|---|---|---|
| Full Compression | Experimental | The LifeWrap compression garment will be fully secured with all straps. Receives: Device: LifeWrap Compression Garment |
| Abdominal and Pelvic Compression | Experimental | The Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured. Receives: Device: LifeWrap Compression Garment |
| Lower Limb Compression | Experimental | The Lifewrap compression garment calf and ankle straps only will be secured. Receives: Device: LifeWrap Compression Garment |
| No Compression | No intervention | None of the LifeWrap compression garment straps will be secured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic Heart Rate (HR) Change
The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.
Measured: Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR
Secondary outcomes (7)
Maximum Upright Heart Rate
The maximum heart rate during minutes 5-10 of each HUT. The maximum heart rate during each of the study arms will be compared.
Measured: During minutes 5-10 of the HUT
Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating
Subjective symptom scoring as reported by participant during each study arm. The VOSS evaluates 9 symptoms on a 0 to 10 scale with 0 being no symptom to 10 being worst ever symptom. The total score ranges from 0-90, with a higher score being more severe symptoms.
The 9 symptoms are mental clouding, blurred vision, shortness of breath, rapid heartbeat, tremulousness, chest discomfort, headache, lightheadedness, and nausea. The participant's VOSS score will be compared across the 4 arms of this study.
The VOSS score has been previously used in multiple publications
Measured: After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)
Change in Systolic Blood Pressure (SBP)
Change in continuous systolic blood pressure between supine and HUT during each study arm.
Measured: During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
Changes in Stroke Volume
Change in Stroke Volume from supine to HUT in each of the study arms.
Measured: During the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
Change in Cardiac Output (CO)
Change in Cardiac Output from supine to HUT in each of the study arms.
Measured: During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
Change in Systemic Vascular Resistance (SVR)
Change in Systemic Vascular Resistance from supine to HUT in each of the study arms.
Measured: During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals.
Change in Cerebral Blood Flow Velocity (CBFV)
Change in cerebral blood flow from supine to HUT in each of the study arms.
Measured: During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start12 Jul 2018
- Primary completion1 Apr 2020
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postural Tachycardia SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There will be 4 compression conditions based on strap configuration of the Lifewrap garment: full abdominal and lower extremity compression, abdominal only compression, lower extremity only compression and no compression. The order of these interventions will be randomized.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Satish Raj, University of Calgary
- Investigators
- Satish R Raj, MD, MSCI, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484273
- Sponsor's protocol ID
- REB17-2393
- Status last verified
- Sep 2021
- First submitted
- 19 Mar 2018
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bourne KM, Sheldon RS, Hall J, Lloyd M, Kogut K, Sheikh N, Jorge J, Ng J, Exner DV, Tyberg JV, Raj SR. Compression Garment Reduces Orthostatic Tachycardia and Symptoms in Patients With Postural Orthostatic Tachycardia Syndrome. J Am Coll Cardiol. 2021 Jan 26;77(3):285-296. doi: 10.1016/j.jacc.2020.11.040.
PubMed 33478652
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Compression in Postural Tachycardia Syndrome (POTS): Effects on Orthostatic Tolerance
- ClinicalTrials.gov ID
- NCT03484273
- Acronym / sponsor ID
- REB17-2393
- Conditions
- Postural Tachycardia Syndrome
- Keywords
- Tilt Table, Compression, Dysautonomia, POTS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Posted 12 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
When an individual with Postural Tachycardia Syndrome (POTS) stands up, their heart rate increases significantly (>30BPM) and they may experience symptoms such as lightheadedness, dizziness, shortness of breath, nausea and mental confusion.
One commonly prescribed treatment for POTS is compression garments. Compression garments squeeze veins to help return blood back to the heart, which may decrease heart rate and symptoms on standing. However, there is little research about the effectiveness of compression in adults with POTS.
In this study, the investigators will use the Lifewrap garment, which compresses the abdomen, pelvis and lower extremities, to evaluate the effectiveness of compression in POTS. The investigators will use a head up tilt (HUT) which will simulate standing. The study participant will participate in 4x 10 minute HUTs wearing 4 different compression configurations:
- full abdomen and lower extremity compression
- abdominal only compression
- leg only compression
- No compression
The investigators hypothesize that with full compression, the participant's heart rate increase from lying down to upright will be lower than when they are not wearing any compression. The investigators will also ask the participant about their symptoms when they are upright.
The results of this study could demonstrate the potential benefits of compression and what configuration is most effective. These findings could rapidly translate to the clinical setting, providing improved care.
Detailed description
Postural Tachycardia Syndrome (POTS) is a chronic form of orthostatic intolerance marked by a significant and sustained increase in heart rate (HR) upon positional change from supine to standing (>30 beats/min [bpm]) in the absence of orthostatic hypotension (<20/10 mmHg decrease). Symptoms must be present for >6 months and other causes of orthostatic tachycardia must be ruled out. Individuals with POTS report orthostatic symptoms including palpitations, lightheadedness, and mental clouding, which improve on recumbence. The vast majority of individuals diagnosed with POTS are women age 13-50 years.
Upon standing, approximately 500 mL of blood immediately redistributes from the thorax down to the abdomen, buttocks and legs. This leads to sympathetic activation as the baroreceptors sense less pressure. In a healthy individual, HR initially increases 10-20 bpm, and the systolic blood pressure (BP) decreases by approximately 5 mmHg. However, in an individual with POTS, this compensatory mechanism is impaired and HR will increase by >30 bpm and remain at this elevated rate for the duration of standing. In some individuals with POTS, upon standing cerebral blood flow velocity decreases. In other individuals, oscillation of cerebral blood flow due to failure of cerebral autoregulatory mechanisms is observed.
Current treatment of POTS involves pharmacological and non-pharmacological intervention including salt and fluid loading, exercise, and physical countermanuevers. There are no approved medications for use in POTS and all use is off label. Compression garments are also often prescribed. Abdominal/lower extremity compression garments provide pressure to the blood vessels in the legs, thighs and abdomen which can minimize blood pooling and lead to improved blood return to the heart. One such garment is the Lifewrap Non-pneumatic AntiShock garment (NASG), indicated in post-partum hypovolemia.
A pediatric study (n=20) found that orthostatic tachycardia and symptoms were decreased during head up tilt (HUT), with the use of a different NASG compression garment vs. no compression. However, there is no data to validate the efficacy of compression in adults POTS, and also no data to determine which type of compression is most beneficial (e.g. lower leg only, abdomen only, combination).
The investigators hypothesize that the use of the Lifewrap NASG compression garment in a fully applied configuration will decrease orthostatic tachycardia and orthostatic symptoms during a 10 minute HUT vs. no compression garment. The investigators will complete a 4-way randomized crossover study of HUTs with compression applied by the LifeWrap NSAG in at attempt to demonstrate decreased orthostatic tachycardia and increased orthostatic tolerance in individuals with POTS. If successful, this study could provide needed evidence that compression in POTS is a successful non-pharmacological treatment modality, and as well, what type of compression is the most beneficial to patients with this syndrome. These findings could rapidly translate to the clinical setting and improve patient care.
The study participant will complete 4x 10min HUTs during a single study day. There will be 4 compression conditions based on strap configuration of the Lifewrap garment: (1) full abdominal and lower extremity compression, (2) abdominal only compression, (3) lower extremity only compression and (4) no compression. A pressure sensor will used to measure the magnitude of compression pressure applied. The study will be conducted on a tilt table in a human physiology research and procedure room. Each intervention phase in the protocol will involve a supine baseline assessment period of 10 minutes followed by a 10 min HUT (80 degrees). There will be a 20 min recovery periods between each HUT. The study will take approximately 4 hours.
The study participant will be instrumented in a fasting state and on an empty bladder. The investigators will apply skin electrodes to continuously monitor heart rate and record an ECG. BP will be monitored continuously using a finger volume clamp method (Nexfin, Edwards Lifesciences) and calibrated with intermittent brachial cuff measurements (Vital-Guard 450C Patient Care Monitor, IVY Medical). From the continuous BP waveform, the investigators can obtain an estimate of stroke volume, cardiac output, and systemic vascular resistance (Modelflow). Middle cerebral blood flow velocity will be assessed using transcranial doppler.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- There will be 4 compression conditions based on strap configuration of the Lifewrap garment: full abdominal and lower extremity compression, abdominal only compression, lower extremity only compression and no compression. The order of these interventions will be randomized.
| Arm | Type | Receives |
|---|---|---|
| Full Compression | Experimental | Device: LifeWrap Compression GarmentThe LifeWrap compression garment will be fully secured with all straps. |
| Abdominal and Pelvic Compression | Experimental | Device: LifeWrap Compression GarmentThe Lifewrap compression garment abdominal, pelvic and upper thigh straps only will be secured. |
| Lower Limb Compression | Experimental | Device: LifeWrap Compression GarmentThe Lifewrap compression garment calf and ankle straps only will be secured. |
| No Compression | No intervention | –None of the LifeWrap compression garment straps will be secured. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Physician diagnosis of Postural Tachycardia Syndrome (POTS)
- Age 18-60 years (we are an adult group and we do not see pediatric patients clinically and do not have appropriate pediatric expertise)
- Male and Female
- Able and willing to provide informed consent
- Ability to travel to Libin Cardiovascular Institute of Alberta Autonomic Testing Lab at the University of Calgary, Calgary, AB.
Key exclusion criteria (5 listed)
- Overt cause for postural tachycardia, i.e., acute dehydration
- Participants with somatization or severe anxiety symptoms will be excluded (as they may not tolerated study procedures)
- Pregnant women
- Inability to tolerate compression garment for the duration of the study
- Other factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies
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 |
|---|---|---|
| LifeWrap Compression GarmentNon-Pneumatic Anti-Shock (NASG) compression garment comprised of neoprene with velcro closures. | Device | Abdominal and Pelvic Compression, Full Compression, Lower Limb Compression |
Primary outcome
Orthostatic Heart Rate (HR) Change
Time frame: Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR
The primary outcome measure will be the magnitude of HR change from supine to HUT (max HR between 5-10 min of HUT) for each study arm.
7 secondary outcomes
Maximum Upright Heart Rate
Time frame: During minutes 5-10 of the HUT
Differences in Vanderbilt Orthostatic Symptom Score (VOSS) Symptom Rating
Time frame: After t=10 of the 10min HUT (or sooner if HUT has to be terminated early due to symptoms)
Change in Systolic Blood Pressure (SBP)
Time frame: During the baseline before the HUT and the SBP correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
Changes in Stroke Volume
Time frame: During the baseline before the HUT and the SV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
Change in Cardiac Output (CO)
Time frame: During the baseline before the HUT and the CO correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
Change in Systemic Vascular Resistance (SVR)
Time frame: During the baseline before the HUT and the SVRcorrelating with the maximum HR during 5-10 min HUT, recorded at 1min intervals.
Change in Cerebral Blood Flow Velocity (CBFV)
Time frame: During the baseline before the HUT and the CBFV correlating with the maximum HR during 5-10 min HUT, recorded at 1 min intervals.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33478652Bourne KM, Sheldon RS, Hall J, Lloyd M, Kogut K, Sheikh N, Jorge J, Ng J, Exner DV, Tyberg JV, Raj SR. Compression Garment Reduces Orthostatic Tachycardia and Symptoms in Patients With Postural Orthostatic Tachycardia Syndrome. J Am Coll Cardiol. 2021 Jan 26;77(3):285-296. doi: 10.1016/j.jacc.2020.11.040.
- 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.
Satish R Raj, MD, MSCI principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeWrap Compression Garment in people with Postural Tachycardia Syndrome, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 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 22 Oct 2021. 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 Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic Heart Rate (HR) Change (time frame: Maximum HR between 5-10min HUT MINUS the baseline (pre-tilt) HR). 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 NCT03484273, which also lists 1 linked publication.
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 22 Oct 2021.