Pregnancy RelatedEVANCT03402971
The Right Heart During and After Pregnancy - an Echocardiographic Study
An observational study of Pregnancy Related, run by Gero Bunniger at 1 site in Germany.
Trial summary
The main goal is to establish echocardiographic reference values of the right heart for pregnant women, assuming they differ significantly from those of non pregnant women of same age. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- echocardiography
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 2 Nov 2017to 2 Nov 2024
- 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 years and older
- Women only
- Adult, Older adult
Study population: women over 18 years, actual mean age is 33y
Who may be able to join
- pregnant
- 18years or older
Who cannot join
- acute illness demanding instant therapy
- poor or none sonographic results
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Gießen
Giessen, Hesse, 35392
Gero Bunniger
Khodr Tello, MD
About this study
Official title: Das Rechte Herz in Der Schwangerschaft. Echokardiographische Verlaufskontrollen Des Rechten Herzens während Und Nach Der Schwangerschaft.
The main goal is to establish echocardiographic reference values of the right heart for pregnant women, assuming they differ significantly from those of non pregnant women of same age.
Therefore the investigators will use existing reference values published by American society of echocardiography and European Association of Echocardiography. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.
Read the detailed description
A lot of lung diseases affect the heart, too - especially the right heart. Well known examples are pulmonary embolism or pulmonary hypertension. But rather unknown is the fact, that right heart function presents as a prognostic parameter in a lot of (left heart) diseases, for example myocardial infarction, atrial fibrillation, left heart failure, but also in chronic obstructive pulmonary disease (COPD) or may be even diabetes mellitus. Since the left part of the heart has been studied by researchers more than fifty years, the right heart has moved into scientific focus not long ago.
The tool of choice to examine the living heart is echocardiography. There are no relevant risks or complications.
During an echocardiographic examination a lot of parameters are collected. To judge data in a clinical way reference values belonging to healthy persons are essential. Those values are highly dependant on sex, body size, age etc.
Since pregnancy changes a lot in the human body, reference values from non pregnant woman of same age (published by American society of echocardiography and European Association of Echocardiography) are presumably not representative. So the investigators want to establish echocardiographic reference values of the right heart for pregnant women. Therefore an echocardiographic examination will be applied within each trimester of pregnancy and after delivery. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.
- Conditions
- Pregnancy Related
- Being tested
- echocardiography
- Keywords
- right heart, pregnancy, echocardiography, reference values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echocardiographyDiagnostic test
Also called parallel EKG
echocardiography focused on right heart: Parameters include RV enddiastolic diameter basal, mid-cavity and longitudinal, RVOT distal, pulmonal outflow AT and AT/ET, endsystolic RA area. RV wall thickness, TAPSE, S', tricuspidal E/A, E/e', RIMP. V. Cava to estimate CVP and sPAP.
| Study group | Role | What they receive |
|---|---|---|
| healthy pregnant+healthy fetus | healthy pregnant women with suspected healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery Receives: Diagnostic Test: echocardiography | |
| non healthy pregnant | non healthy women with suspected healthy or unhealthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery Receives: Diagnostic Test: echocardiography | |
| non healthy fetus | healthy or non healthy pregnant women with suspected non healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery Receives: Diagnostic Test: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in right ventricular (RV) enddiastolic diameter basal
The investigators measure right ventricular (RV) enddiastolic diameter basal (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in RV enddiastolic diameter mid-cavitiy
The investigators measure right ventricular RV enddiastolic diameter mid-cavity (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in RV enddiastolic diameter longitudinal
The investigators measure right ventricular RV enddiastolic diameter longitudinal (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in right ventricular outflow tract (RVOT) distal
The investigators measure RVOT distal (unit: mm), via echocardiography in parasternal short-axis view, EKG-controlled.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in right atrial (RA) endsystolic area
The investigators measure RA endsystolic area (unit: cm²), via echocardiography in apical 4 Chamber view, EKG-controlled.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in RV wall thickness
The investigators measure RV wall thickness (unit: mm), via echocardiography in subcostal view, EKG-controlled. RV wall >5mm indicates RV hypertrophy.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in tricuspid annular plane systolic excursion (TAPSE)
The investigators measure TAPSE (unit: mm), via echocardiography in apical 4 Chamber view + M-Mode at lateral tricuspid annulus, EKG-controlled. TAPSE is a parameter describing systolic RV-function.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in S' velocity
The investigators measure S' velocity (unit: cm/sec), via echocardiography in apical 4 Chamber view + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. S' is a parameter describing systolic RV-function.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in tricuspid E/A ratio
The investigators measure tricuspidal E/A ratio (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed wave doppler over tricuspid inflow, EKG-controlled. Tricuspid E/A ratio is a parameter describing diastolic RV-function.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in tricuspid E/e' ratio
The investigators measure tricuspid E/e' ratio (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed wave doppler over tricuspid inflow + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. Tricuspid E/e' ratio is a parameter describing diastolic RV-function.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in right index of myocardial performance (RIMP)
The investigators measure RIMP (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. RIMP is calculated (isovolumic contraction time + isovolumic relaxation time) devided by (ejection time). RIMP is a parameter describing systolic RV-function.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in inferior vena cava (IVC) diameter at end-expiration
The investigators measure IVC (unit: mm) via echocardiography subcostal or IVC view at end-expiration. IVC diameter correlates with central venous pressure.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in inferior vena cava (IVC) diameter with sniff test.
The investigators measure IVC (unit: mm) via echocardiography subcostal or IVC view at forced inspiration. IVC diameter correlates with central venous pressure.
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in tricuspid regurgitation peak velocity
The investigators measure tricuspid regurgitation peak velocity (unit: m/sec) via echocardiography in apical 4 Chamber view + continuous wave doppler over tricuspid inflow respectively tricuspid regurgitation, if there is a tricuspid insufficiency, EKG-controlled. Tricuspid regurgitation peak velocity correlates with systolic pulmonary artery pressure (sPAP).
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
change in RV outflow tract acceleration time (RVOT-AT)
The investigators measure RVOT-AT (unit: msec) via echocardiography in parasternal short-axis view + pulsed wave doppler over pulmonal valve, EKG-controlled. RVOT-AT correlates with systolic pulmonary artery pressure (sPAP).
Measured: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start2 Nov 2017
- Primary completion2 Nov 2023 (estimated)
- Study completion2 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gero Bunniger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gero Bunniger, University of Giessen
- Investigators
- Henning Gall, Prof., MD, Principal investigator, Pulmology, Department of pulmonal Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402971
- Sponsor's protocol ID
- 130/17
- Acronym
- EVA
- Status last verified
- Apr 2021
- First submitted
- 28 Dec 2017
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Das Rechte Herz in Der Schwangerschaft. Echokardiographische Verlaufskontrollen Des Rechten Herzens während Und Nach Der Schwangerschaft.
- ClinicalTrials.gov ID
- NCT03402971
- Acronym / sponsor ID
- EVA / 130/17
- Conditions
- Pregnancy Related
- Keywords
- right heart, pregnancy, echocardiography, reference values
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Gero BunnigerUniversity, hospital or other
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 2 Nov 2023 (estimated)
- Study completion
- 2 Nov 2024 (estimated)
- First posted
- 18 Jan 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.
The main goal is to establish echocardiographic reference values of the right heart for pregnant women, assuming they differ significantly from those of non pregnant women of same age.
Therefore the investigators will use existing reference values published by American society of echocardiography and European Association of Echocardiography. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.
Detailed description
A lot of lung diseases affect the heart, too - especially the right heart. Well known examples are pulmonary embolism or pulmonary hypertension. But rather unknown is the fact, that right heart function presents as a prognostic parameter in a lot of (left heart) diseases, for example myocardial infarction, atrial fibrillation, left heart failure, but also in chronic obstructive pulmonary disease (COPD) or may be even diabetes mellitus. Since the left part of the heart has been studied by researchers more than fifty years, the right heart has moved into scientific focus not long ago.
The tool of choice to examine the living heart is echocardiography. There are no relevant risks or complications.
During an echocardiographic examination a lot of parameters are collected. To judge data in a clinical way reference values belonging to healthy persons are essential. Those values are highly dependant on sex, body size, age etc.
Since pregnancy changes a lot in the human body, reference values from non pregnant woman of same age (published by American society of echocardiography and European Association of Echocardiography) are presumably not representative. So the investigators want to establish echocardiographic reference values of the right heart for pregnant women. Therefore an echocardiographic examination will be applied within each trimester of pregnancy and after delivery. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy pregnant+healthy fetus | – | Diagnostic Test: echocardiographyhealthy pregnant women with suspected healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery |
| non healthy pregnant | – | Diagnostic Test: echocardiographynon healthy women with suspected healthy or unhealthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery |
| non healthy fetus | – | Diagnostic Test: echocardiographyhealthy or non healthy pregnant women with suspected non healthy fetus will get one echocardiography examination each trimester of pregnancy and one after delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- women over 18 years, actual mean age is 33y
Key inclusion criteria (2 listed)
- pregnant
- 18years or older
Key exclusion criteria (2 listed)
- acute illness demanding instant therapy
- poor or none sonographic results
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 |
|---|---|---|
| echocardiographyAlso: parallel EKGechocardiography focused on right heart: Parameters include RV enddiastolic diameter basal, mid-cavity and longitudinal, RVOT distal, pulmonal outflow AT and AT/ET, endsystolic RA area. RV wall thickness, TAPSE, S', tricuspidal E/A, E/e', RIMP. V. Cava to estimate CVP and sPAP. | Diagnostic test | healthy pregnant+healthy fetus, non healthy fetus, non healthy pregnant |
Primary outcome
change in right ventricular (RV) enddiastolic diameter basal
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure right ventricular (RV) enddiastolic diameter basal (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.
change in RV enddiastolic diameter mid-cavitiy
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure right ventricular RV enddiastolic diameter mid-cavity (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.
change in RV enddiastolic diameter longitudinal
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure right ventricular RV enddiastolic diameter longitudinal (unit: mm), via echocardiography in apical 4 Chamber view, EKG-controlled.
change in right ventricular outflow tract (RVOT) distal
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure RVOT distal (unit: mm), via echocardiography in parasternal short-axis view, EKG-controlled.
change in right atrial (RA) endsystolic area
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure RA endsystolic area (unit: cm²), via echocardiography in apical 4 Chamber view, EKG-controlled.
change in RV wall thickness
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure RV wall thickness (unit: mm), via echocardiography in subcostal view, EKG-controlled. RV wall >5mm indicates RV hypertrophy.
change in tricuspid annular plane systolic excursion (TAPSE)
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure TAPSE (unit: mm), via echocardiography in apical 4 Chamber view + M-Mode at lateral tricuspid annulus, EKG-controlled. TAPSE is a parameter describing systolic RV-function.
change in S' velocity
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure S' velocity (unit: cm/sec), via echocardiography in apical 4 Chamber view + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. S' is a parameter describing systolic RV-function.
change in tricuspid E/A ratio
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure tricuspidal E/A ratio (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed wave doppler over tricuspid inflow, EKG-controlled. Tricuspid E/A ratio is a parameter describing diastolic RV-function.
change in tricuspid E/e' ratio
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure tricuspid E/e' ratio (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed wave doppler over tricuspid inflow + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. Tricuspid E/e' ratio is a parameter describing diastolic RV-function.
change in right index of myocardial performance (RIMP)
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure RIMP (unit: no unit), via echocardiography in apical 4 Chamber view + pulsed tissue Doppler velocity of the lateral tricuspid annulus, EKG-controlled. RIMP is calculated (isovolumic contraction time + isovolumic relaxation time) devided by (ejection time). RIMP is a parameter describing systolic RV-function.
change in inferior vena cava (IVC) diameter at end-expiration
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure IVC (unit: mm) via echocardiography subcostal or IVC view at end-expiration. IVC diameter correlates with central venous pressure.
change in inferior vena cava (IVC) diameter with sniff test.
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure IVC (unit: mm) via echocardiography subcostal or IVC view at forced inspiration. IVC diameter correlates with central venous pressure.
change in tricuspid regurgitation peak velocity
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure tricuspid regurgitation peak velocity (unit: m/sec) via echocardiography in apical 4 Chamber view + continuous wave doppler over tricuspid inflow respectively tricuspid regurgitation, if there is a tricuspid insufficiency, EKG-controlled. Tricuspid regurgitation peak velocity correlates with systolic pulmonary artery pressure (sPAP).
change in RV outflow tract acceleration time (RVOT-AT)
Time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery
The investigators measure RVOT-AT (unit: msec) via echocardiography in parasternal short-axis view + pulsed wave doppler over pulmonal valve, EKG-controlled. RVOT-AT correlates with systolic pulmonary artery pressure (sPAP).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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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.
Henning Gall, Prof., MD principal investigator
Pulmology, Department of pulmonal Hypertension
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 Pregnancy Related, run by Gero Bunniger 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 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gero Bunniger (+49641 985 56082, gero.bunniger@innere.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in right ventricular (RV) enddiastolic diameter basal (time frame: first examination within 1st to 12th week of pregnancy, second examination within 13th to 28th week of pregnancy, third examination after 28th week of pregnancy and before delivery, fourth examination will take place at least 14 days after delivery). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2021.