Heart FailurePhase 4DIURESIS-CHFNCT01973335
Acetazolamide and Spironolactone to Increase Natriuresis in Congestive Heart Failure
A Phase 4 study testing Combination therapy with acetazolamide and low-dose loop diuretics, High-dose loop diuretics and Upfront therapy with oral spironolactone in people with Heart Failure, run by Hasselt University at 2 sites in Belgium.
Trial summary
This study has two primary objectives: 1. To compare combination therapy with acetazolamide and low-dose loop diuretics versus high-dose loop diuretics (standard of care) in patients with acute decompensated heart failure at high risk for diuretic resistance. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Combination therapy with acetazolamide and low-dose loop diuretics, High-dose loop diuretics and Upfront therapy with oral spironolactone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesBelgium
- Study dates
- Nov 2013to Oct 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 years and able to give informed consent
- Clinical diagnosis of acute decompensated heart failure within the previous 8 h
- At least two clinical signs of congestion (edema, ascites, jugular venous distension, or pulmonary vascular congestion on chest radiography)
- Maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide (1 mg bumetanide = 40 mg furosemide = 20 mg torsemide) for at least 1 month before hospital admission
- NT-proBNP >1000 ng/L
- Left ventricular ejection fraction <50%
Show all 10Show fewer
- At least one out of three of the following criteria:
- Serum sodium <136 mmol/L
- Serum urea/creatinine ratio >50 (comparable to a BUN/creatinine ratio >25)
- Admission serum creatinine increased with >0.3 mg/dL compared to previous value within 3 months before admission
Who cannot join
- History of cardiac transplantation and/or ventricular assist device
- Concurrent diagnosis of an acute coronary syndrome defined as typical chest pain and/or electrocardiographic changes in addition to a troponin rise >99th percentile
- Mean arterial blood pressure <65 mmHg, or systolic blood pressure <90 mmHg at the moment of admission
- Use of intravenous inotropes, vasopressors or nitroprusside at any time point during the study
- A baseline estimated glomerular filtration rate <15 mL/min/1.73m² according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the moment of inclusion
- Use of renal replacement therapy or ultrafiltration before study inclusion
Show all 10Show fewer
- Treatment with acetazolamide within the previous month
- Treatment with ≥2 mg bumetanide or an equivalent dose during the index hospitalization before randomization
- Use of diuretics, vasopressin antagonists or mineralocorticoid receptor antagonist not specified by the protocol
- Exposure to nephrotoxic agents (i.e. contrast dye) anticipated within 3 days
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
University Hospital Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Diamox/Aldactone to Increase the URinary Excretion of Sodium: an Investigational Study in Congestive Heart Failure
This study has two primary objectives:
- To compare combination therapy with acetazolamide and low-dose loop diuretics versus high-dose loop diuretics (standard of care) in patients with acute decompensated heart failure at high risk for diuretic resistance.
- To demonstrate the safety and efficacy of upfront therapy with spironolactone in addition to loop diuretic therapy in patients with acute decompensated heart failure at high risk for diuretic resistance.
- Conditions
- Heart Failure
- Being tested
- Combination therapy with acetazolamide and low-dose loop diuretics, High-dose loop diuretics, Upfront therapy with oral spironolactone
- Keywords
- acetazolamide, bumetanide, cardio-renal syndrome, diuretics, heart failure, natriuresis, spironolactone
- Medical subject headings
- Heart Failure, Cardio-Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy with acetazolamide and low-dose loop diureticsDrug
Also called Diamox (acetazolamide), Burinex/Bumex (loop diuretics)
- Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.
- Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.
- If diuresis <1,5 L while the patient is still considered volume overloaded by his/her treating cardiologist, the dose of acetazolamide is maintained at 500 mg and the dose of bumetanide is maintained at 2mg.
In case of therapy-refractory congestion, treatment is at the discretion of the treating physician, but addition of chlorthalidone 50 mg PO is recommended by the investigators as a first-line option.
High-dose loop diureticsDrug
Also called Burinex/Bumex
- Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.
- Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.
- If diuresis <1,5 L while the patient is still considered volume overloaded by the treating cardiologist, the dose of bumetanide is doubled.
In case of therapy-refractory congestion, treatment is at the discretion of the treating physician, but addition of chlorthalidone 50 mg PO is recommended by the investigators as a first-line option.
Upfront therapy with oral spironolactoneDrug
Also called Aldactone
Patients randomized to this group receive oral spironolactone (25mg) immediately after randomization and in the morning of each subsequent day unless the serum potassium level is >5 mmol/L.
Note: Investigators and treating physicians are blinded to treatment allocation for this arm, but no matching placebo is provided, so patients are not.
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide/low-dose loop diuretics, upfront spironolactone | Experimental | 2x2 factorial design: This group is the experimental group for both study interventions (acetazolamide and upfront spironolactone).
See interventions for more details. Receives: Drug: Combination therapy with acetazolamide and low-dose loop diuretics; Drug: Upfront therapy with oral spironolactone |
| High-dose loop diuretics, upfront spironolactone | Experimental | 2x2 factorial design: This group is the experimental group for the study intervention with upfront spironolactone. This group receives high-dose loop diuretics as an active comparator to the study intervention with acetazolamide.
See interventions for more details. Receives: Drug: High-dose loop diuretics; Drug: Upfront therapy with oral spironolactone |
| Acetazolamide/low-dose loop diuretics, no spironolactone | Experimental | 2x2 factorial design: This group is the experimental group for the study intervention with acetazolamide. This group receives no intervention with regards to the spironolactone arm.
See interventions for more details. Receives: Drug: Combination therapy with acetazolamide and low-dose loop diuretics |
| High-dose loop diuretics, no spironolactone | Active comparator | 2x2 factorial design: This group receives high-dose loop diuretics as an active comparator to the study intervention with acetazolamide. This group receives no intervention with regards to the spironolactone arm.
See interventions for more details. Receives: Drug: High-dose loop diuretics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetazolamide Arm: Natriuresis 24 h
For the acetazolamide arm of the study, the primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 h after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L). Subsequently, patients receiving acetazolamide and low-dose loop diuretics (both the groups with and without upfront spironolactone together) are compared to patients not receiving acetazolamide but high-dose loop diuretics instead (both the groups with or without upfront spironolactone together)
Measured: 24h
Spironolactone Arm: Incidence of Hypo- (Serum Potassium <3.5 mmol/L) or Hyperkalemia (Serum Potassium >5.0 mmol/L)
For the spironolactone arm of the study, the primary end-point is the incidence of either hypo- (serum potassium <3.5 mmol/L) or hyperkalemia (serum potassium >5.0 mmol/L) at any of 3 morning blood samples at consecutive days after randomization. Patients receiving upfront spironolactone (both the group receiving acetazolamide+low dose loop diuretics and the group receiving high-dose loop diuretic therapy) are compared with them receiving no spironolactone (both the group receiving acetazolamide+low dose loop diuretics and the group receiving high-dose loop diuretic therapy).
Measured: 72h
Secondary outcomes (5)
NT-proBNP Change After 72 h
Relative NT-proBNP change (%) after 72 h compared to baseline.
Measured: 72h
Number of Participants With Worsening Renal Function
Worsening renal function is defined as a rise in serum creatine >0.3 mg/dL or a >20% decrease in estimated glomerular filtration rate by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula compared to baseline at any time point before 72 h. Serum creatinine values are assessed at three consecutive mornings after study inclusion.
Measured: 72h
Persistent Renal Impairment
Persistent renal impairment is defined as a persistently elevated serum creatine >0.3mg/dL or >20% decrease in estimated glomerular filtration rate by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, above the baseline value of the patient and will be assessed on a scheduled follow-up appointment 4 weeks after hospital discharge.
Measured: 4 weeks after hospital discharge
Peak Plasma Aldosterone Concentration After 72 h
At three consecutive mornings after study inclusion, blood samples will be taken to assess plasma aldosterone levels. The highest value will constitute the peak plasma aldosterone concentration (ng/L).
Measured: 72h
Peak Plasma Renin Activity After 72 h
At three consecutive mornings after study inclusion, blood samples will be taken to assess plasma renin activity. The highest value will constitute the peak plasma renin activity (ng/mL/h).
Measured: 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2017
- Study completionOct 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Wilfried Mullens, MD PhD, Ziekenhuis Oost-Limburg
- Investigators
- Wilfried Mullens, M.D. Ph.D., Principal investigator, Ziekenhuis Oost-LimburgFrederik H. Verbrugge, M.D. Ph.D., Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01973335
- Sponsor's protocol ID
- ZOL-DIURESIS-CHF
- Acronym
- DIURESIS-CHF
- Status last verified
- May 2019
- First submitted
- 25 Oct 2013
- Last updated
- 21 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Verbrugge FH, Martens P, Ameloot K, Haemels V, Penders J, Dupont M, Tang WHW, Droogne W, Mullens W. Spironolactone to increase natriuresis in congestive heart failure with cardiorenal syndrome. Acta Cardiol. 2019 Apr;74(2):100-107. doi: 10.1080/00015385.2018.1455947. Epub 2018 Mar 27.
PubMed 29587582Verbrugge FH, Martens P, Ameloot K, Haemels V, Penders J, Dupont M, Tang WHW, Droogne W, Mullens W. Acetazolamide to increase natriuresis in congestive heart failure at high risk for diuretic resistance. Eur J Heart Fail. 2019 Nov;21(11):1415-1422. doi: 10.1002/ejhf.1478. Epub 2019 May 9.
PubMed 31074184
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diamox/Aldactone to Increase the URinary Excretion of Sodium: an Investigational Study in Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01973335
- Acronym / sponsor ID
- DIURESIS-CHF / ZOL-DIURESIS-CHF
- Conditions
- Heart Failure
- Keywords
- acetazolamide, bumetanide, cardio-renal syndrome, diuretics, heart failure, natriuresis, spironolactone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg, Universitaire Ziekenhuizen KU Leuven
- Study start
- Nov 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Posted 21 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has two primary objectives:
- To compare combination therapy with acetazolamide and low-dose loop diuretics versus high-dose loop diuretics (standard of care) in patients with acute decompensated heart failure at high risk for diuretic resistance.
- To demonstrate the safety and efficacy of upfront therapy with spironolactone in addition to loop diuretic therapy in patients with acute decompensated heart failure at high risk for diuretic resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide/low-dose loop diuretics, upfront spironolactone | Experimental | Drug: Combination therapy with acetazolamide and low-dose loop diuretics, Drug: Upfront therapy with oral spironolactone2x2 factorial design: This group is the experimental group for both study interventions (acetazolamide and upfront spironolactone). See interventions for more details. |
| High-dose loop diuretics, upfront spironolactone | Experimental | Drug: High-dose loop diuretics, Drug: Upfront therapy with oral spironolactone2x2 factorial design: This group is the experimental group for the study intervention with upfront spironolactone. This group receives high-dose loop diuretics as an active comparator to the study intervention with acetazolamide. See interventions for more details. |
| Acetazolamide/low-dose loop diuretics, no spironolactone | Experimental | Drug: Combination therapy with acetazolamide and low-dose loop diuretics2x2 factorial design: This group is the experimental group for the study intervention with acetazolamide. This group receives no intervention with regards to the spironolactone arm. See interventions for more details. |
| High-dose loop diuretics, no spironolactone | Active comparator | Drug: High-dose loop diuretics2x2 factorial design: This group receives high-dose loop diuretics as an active comparator to the study intervention with acetazolamide. This group receives no intervention with regards to the spironolactone arm. See interventions for more details. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Older than 18 years and able to give informed consent
- Clinical diagnosis of acute decompensated heart failure within the previous 8 h
- At least two clinical signs of congestion (edema, ascites, jugular venous distension, or pulmonary vascular congestion on chest radiography)
- Maintenance therapy with oral loop diuretics at a dose of at least 1 mg bumetanide (1 mg bumetanide = 40 mg furosemide = 20 mg torsemide) for at least 1 month before hospital admission
- NT-proBNP >1000 ng/L
Key exclusion criteria (10 listed)
- History of cardiac transplantation and/or ventricular assist device
- Concurrent diagnosis of an acute coronary syndrome defined as typical chest pain and/or electrocardiographic changes in addition to a troponin rise >99th percentile
- Mean arterial blood pressure <65 mmHg, or systolic blood pressure <90 mmHg at the moment of admission
- Use of intravenous inotropes, vasopressors or nitroprusside at any time point during the study
- A baseline estimated glomerular filtration rate <15 mL/min/1.73m² according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the moment of inclusion
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 |
|---|---|---|
| Combination therapy with acetazolamide and low-dose loop diureticsAlso: Diamox (acetazolamide), Burinex/Bumex (loop diuretics)* Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist. * Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist. * If diuresis <1,5 L while the patient is still considered volume overloaded by his/her treating cardiologist, the dose of acetazolamide is maintained at 500 mg and the dose of bumetanide is maintained at 2mg. In case of therapy-refractory congestion, treatment is at the discretion of the treating physician, but addition of chlorthalidone 50 mg PO is recommended by the investigators as a first-line option. | Drug | Acetazolamide/low-dose loop diuretics, no spironolactone, Acetazolamide/low-dose loop diuretics, upfront spironolactone |
| High-dose loop diureticsAlso: Burinex/Bumex* Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization. * Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist. * If diuresis <1,5 L while the patient is still considered volume overloaded by the treating cardiologist, the dose of bumetanide is doubled. In case of therapy-refractory congestion, treatment is at the discretion of the treating physician, but addition of chlorthalidone 50 mg PO is recommended by the investigators as a first-line option. | Drug | High-dose loop diuretics, no spironolactone, High-dose loop diuretics, upfront spironolactone |
| Upfront therapy with oral spironolactoneAlso: AldactonePatients randomized to this group receive oral spironolactone (25mg) immediately after randomization and in the morning of each subsequent day unless the serum potassium level is >5 mmol/L. Note: Investigators and treating physicians are blinded to treatment allocation for this arm, but no matching placebo is provided, so patients are not. | Drug | Acetazolamide/low-dose loop diuretics, upfront spironolactone, High-dose loop diuretics, upfront spironolactone |
Primary outcome
Acetazolamide Arm: Natriuresis 24 h
Time frame: 24h
For the acetazolamide arm of the study, the primary end-point is total natriuresis after 24 h (mmol). To assess this, urine is collected for 24 h after the first administration of diuretics according to the study protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L). Subsequently, patients receiving acetazolamide and low-dose loop diuretics (both the groups with and without upfront spironolactone together) are compared to patients not receiving acetazolamide but high-dose loop diuretics instead (both the groups with or without upfront spironolactone together)
Spironolactone Arm: Incidence of Hypo- (Serum Potassium <3.5 mmol/L) or Hyperkalemia (Serum Potassium >5.0 mmol/L)
Time frame: 72h
For the spironolactone arm of the study, the primary end-point is the incidence of either hypo- (serum potassium <3.5 mmol/L) or hyperkalemia (serum potassium >5.0 mmol/L) at any of 3 morning blood samples at consecutive days after randomization. Patients receiving upfront spironolactone (both the group receiving acetazolamide+low dose loop diuretics and the group receiving high-dose loop diuretic therapy) are compared with them receiving no spironolactone (both the group receiving acetazolamide+low dose loop diuretics and the group receiving high-dose loop diuretic therapy).
5 secondary outcomes
NT-proBNP Change After 72 h
Time frame: 72h
Number of Participants With Worsening Renal Function
Time frame: 72h
Persistent Renal Impairment
Time frame: 4 weeks after hospital discharge
Peak Plasma Aldosterone Concentration After 72 h
Time frame: 72h
Peak Plasma Renin Activity After 72 h
Time frame: 72h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29587582Verbrugge FH, Martens P, Ameloot K, Haemels V, Penders J, Dupont M, Tang WHW, Droogne W, Mullens W. Spironolactone to increase natriuresis in congestive heart failure with cardiorenal syndrome. Acta Cardiol. 2019 Apr;74(2):100-107. doi: 10.1080/00015385.2018.1455947. Epub 2018 Mar 27.
- Results publication: PubMed 31074184Verbrugge FH, Martens P, Ameloot K, Haemels V, Penders J, Dupont M, Tang WHW, Droogne W, Mullens W. Acetazolamide to increase natriuresis in congestive heart failure at high risk for diuretic resistance. Eur J Heart Fail. 2019 Nov;21(11):1415-1422. doi: 10.1002/ejhf.1478. Epub 2019 May 9.
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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.
Wilfried Mullens, M.D. Ph.D. principal investigator
Ziekenhuis Oost-Limburg
Frederik H. Verbrugge, M.D. Ph.D. principal investigator
Ziekenhuis Oost-Limburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination therapy with acetazolamide and low-dose loop diuretics, High-dose loop diuretics and Upfront therapy with oral spironolactone in people with Heart Failure, run by Hasselt University at 2 sites in Belgium.
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 10 inclusion and 10 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 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2019). 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?
Acetazolamide Arm: Natriuresis 24 h (time frame: 24h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01973335, which also lists 2 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 May 2019.