Heart FailurePhase 4NCT03387605
Effect of Ivabradine in Stage D HF/Cardiogenic Shock Patients on Dobutamine
A Phase 4 study testing Ivabradine in people with Heart Failure and Cardiogenic Shock, run by Loyola University at 1 site in United States.
Trial summary
This is a randomized, double blind, single center trial to study of the effects of Ivabradine vs. Placebo on patients hospitalized for Stage D heart failure (HF)/ and cardiogenic shock (CS) who will require continuous infusion of Dobutamine and have developed sinus tachycardia (ST) (heart rate >100 beats/min). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure, Cardiogenic Shock, Tachycardia
- What is being tested?
- Ivabradine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2018to Jun 2020
- Phase
- Phase 4
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent for the study
- Have current diagnosis of Ischemic and/or non-ischemic cardiomyopathy
- Left ventricular ejection fraction (LVEF) < 30% by echo during the screening
- Sinus rhythm with HR ≥100 bpm
- Systolic blood pressure ≥ 90 mmHg assessed by cuff sphygmomanometer
- CI < 2.2 L/min/m2
- Current symptom(s) of HF (New York Heart Association (NYHA) class IV) at Screening.
- Absence of hypovolemia, defined as a central venous pressure ≥10 mmHg and pulmonary capillary occlusion pressure ≥15 mmHg before administration of Dobutamine
Who cannot join
- Respiratory support with mechanical ventilation
- Circulatory mechanical support
- Atrial pacing with the presence of sick sinus syndrome or sino-atrial block
- Second or third degree atrioventricular (AV) block,
- Atrial fibrillation/flutter
- Amiodarone treatment
Show all 15Show fewer
- Ventricular tachycardia
- Acute coronary syndrome
- Bilirubin > 2.5
- Alanine aminotransferase (ALT) >60 IE/L,
- Serum creatinine >2.5 g/ml)
- Fever and significant infection
- Pregnancy
- Anemia, Hgb < 9.0
- Patients required treated with severe cytochrome CYP3A4 inhibitors drugs Concomitant use of strong CYP3A4 inhibitors will be avoided during the study period
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 60153
Eugenia Raichlin, MD
About this study
Official title: Effect of Ivabradine on Heart Rate and Hemodynamics in Patients With Stage D Heart Failure (HF)/Cardiogenic Shock on Dobutamine Treatment
This is a randomized, double blind, single center trial to study of the effects of Ivabradine vs. Placebo on patients hospitalized for Stage D heart failure (HF)/ and cardiogenic shock (CS) who will require continuous infusion of Dobutamine and have developed sinus tachycardia (ST) (heart rate >100 beats/min).
The aim of the study will be to assess the potential of Ivabradine to slow ST and improve hemodynamics in patients with stage D HF/CS on Dobutamine treatment.
Read the detailed description
This study will explore the hypothesis that Ivabradine will decrease heart rate (HR) and improve hemodynamics in patients with advanced HF on inotropic treatment. This is a randomized, double blind, single center trial will include 40 consecutive patients admitted for Stage D HF/ CS who will require continuous infusion of Dobutamine and will develop ST (HR >100 beats/min).
Eligible patients will be randomized (1:1) using blocked randomization with random block sizes of 2 or 4 to start Ivabradine versus placebo. The procedure of randomization to receive either Ivabradine or placebo twice daily will be performed by computerized sequence generation. The hospital pharmacies will be responsible for drug randomization and dispensing, and the investigators and the patients will be blinded to the treatment option.
Ivabradine will be started 3 hours after Dobutamine initiation at dose 5 mg and further increased in 12 hours to 7.5 mg bid if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm. Increase of Ivabradine dosage will be individually stopped for reasons of safety if three episodes of minimal HRs of less than 70 beats per minute, or a drop in mean blood pressure < 60 mmHg or systolic blood pressure < 80 mmHg occur.
HR, blood pressure and invasive hemodynamics will be monitored, along with standard right heart cath and echocardiogram measurements obtained.
Patients will be followed for a total of 72 hours. The adverse events that will be collected include bradycardia, defined as a heart rate less than 70 bpm, hypotension defined as a systolic blood pressure less than 80 mmHg and any side effect requiring drug discontinuation or dose adjustment. Review of laboratory including renal, hepatic and hematologic counts will be reviewed for any significant changes due to the use of Ivabradine.
- Conditions
- Heart Failure, Cardiogenic Shock, Tachycardia
- Being tested
- Ivabradine, Placebo
- Medical subject headings
- Heart Failure, Shock, Cardiogenic, Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Corlanor
ivabradine or placebo given orally 2 times daily for 72 hours
PlaceboDrug
matching placebo given 2 times daily for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| Ivabradine | Active comparator | Initiation at dose 5 mg PO x 1 dose and further increased in 12 hours to 7.5 mg PO twice per day if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm Receives: Drug: Ivabradine |
| Placebo | Placebo comparator | Matching placebo given PO twice per day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate will be measured and any changes noted
Measured: 72 hours
Secondary outcomes (2)
cardiac index
cardiac index will be assessed by pulmonary artery catheter and any changes noted
Measured: 72 hours
plasma brain natriuretic peptide (BNP) level
Labs will be drawn for plasma BNP blood test and any changes noted
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start15 Mar 2018
- Primary completionJan 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)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
- Parallel groups
- Model description
- Randomized, Double Blind, Placebo Controlled single center study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loyola University
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Eugenia Raichlin, Loyola University
- Investigators
- Eugenia Raichlin, MD, Principal investigator, Loyola University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387605
- Sponsor's protocol ID
- 209939
- Status last verified
- May 2019
- First submitted
- 15 Dec 2017
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reynolds HR, Hochman JS. Cardiogenic shock: current concepts and improving outcomes. Circulation. 2008 Feb 5;117(5):686-97. doi: 10.1161/CIRCULATIONAHA.106.613596. No abstract available.
PubMed 18250279Vasquez A, Kern KB, Hilwig RW, Heidenreich J, Berg RA, Ewy GA. Optimal dosing of dobutamine for treating post-resuscitation left ventricular dysfunction. Resuscitation. 2004 May;61(2):199-207. doi: 10.1016/j.resuscitation.2004.01.002.
PubMed 15135197Leier CV, Webel J, Bush CA. The cardiovascular effects of the continuous infusion of dobutamine in patients with severe cardiac failure. Circulation. 1977 Sep;56(3):468-72. doi: 10.1161/01.cir.56.3.468.
PubMed 884803Metra M, Nodari S, D'Aloia A, Muneretto C, Robertson AD, Bristow MR, Dei Cas L. Beta-blocker therapy influences the hemodynamic response to inotropic agents in patients with heart failure: a randomized comparison of dobutamine and enoximone before and after chronic treatment with metoprolol or carvedilol. J Am Coll Cardiol. 2002 Oct 2;40(7):1248-58. doi: 10.1016/s0735-1097(02)02134-4.
PubMed 12383572Wynsen JC, O'Brien PD, Warltier DC. Zatebradine, a specific bradycardic agent, enhances the positive inotropic actions of dobutamine in ischemic myocardium. J Am Coll Cardiol. 1994 Jan;23(1):233-41. doi: 10.1016/0735-1097(94)90526-6.
PubMed 8277087Aidonidis I, Brachmann J, Rizos I, Zacharoulis A, Stavridis I, Toutouzas P, Kubler W. Electropharmacology of the bradycardic agents alinidine and zatebradine (UL-FS 49) in a conscious canine ventricular arrhythmia model of permanent coronary artery occlusion. Cardiovasc Drugs Ther. 1995 Aug;9(4):555-63. doi: 10.1007/BF00878087.
PubMed 8547205Hettrick DA, Pagel PS, Lowe D, Tessmer JP, Warltier DC. Increases in inotropic state without change in heart rate: combined use of dobutamine and zatebradine in conscious dogs. Eur J Pharmacol. 1996 Dec 5;316(2-3):237-44. doi: 10.1016/s0014-2999(96)00688-7.
PubMed 8982692Neustein SM, Dimich I, Shiang H, Mezrow C. Role of zatebradine and propranolol in attenuation of tachycardia produced by dobutamine in pigs. Acta Anaesthesiol Scand. 1997 Aug;41(7):849-52. doi: 10.1111/j.1399-6576.1997.tb04799.x.
PubMed 9265927Zhang Y, Mazgalev TN. Cardiac vagal stimulation eliminates detrimental tachycardia effects of dobutamine used for inotropic support. Ann Thorac Surg. 2009 Jul;88(1):117-22. doi: 10.1016/j.athoracsur.2009.04.009.
PubMed 19559207DiFrancesco D, Camm JA. Heart rate lowering by specific and selective I(f) current inhibition with ivabradine: a new therapeutic perspective in cardiovascular disease. Drugs. 2004;64(16):1757-65. doi: 10.2165/00003495-200464160-00003.
PubMed 15301560Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.
PubMed 18757088Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1.
PubMed 20801500Henri C, O'Meara E, De Denus S, Elzir L, Tardif JC. Ivabradine for the treatment of chronic heart failure. Expert Rev Cardiovasc Ther. 2016;14(5):553-61. doi: 10.1586/14779072.2016.1165092. Epub 2016 Mar 28.
PubMed 26967048Tardif JC, O'Meara E, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L, Swedberg K; SHIFT Investigators. Effects of selective heart rate reduction with ivabradine on left ventricular remodelling and function: results from the SHIFT echocardiography substudy. Eur Heart J. 2011 Oct;32(20):2507-15. doi: 10.1093/eurheartj/ehr311. Epub 2011 Aug 29.
PubMed 21875858Fang Y, Debunne M, Vercauteren M, Brakenhielm E, Richard V, Lallemand F, Henry JP, Mulder P, Thuillez C. Heart rate reduction induced by the if current inhibitor ivabradine improves diastolic function and attenuates cardiac tissue hypoxia. J Cardiovasc Pharmacol. 2012 Mar;59(3):260-7. doi: 10.1097/FJC.0b013e31823e5e01.
PubMed 22075752
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ivabradine on Heart Rate and Hemodynamics in Patients With Stage D Heart Failure (HF)/Cardiogenic Shock on Dobutamine Treatment
- ClinicalTrials.gov ID
- NCT03387605
- Acronym / sponsor ID
- 209939
- Conditions
- Heart Failure, Cardiogenic Shock, Tachycardia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Loyola UniversityUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 2 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.
This is a randomized, double blind, single center trial to study of the effects of Ivabradine vs. Placebo on patients hospitalized for Stage D heart failure (HF)/ and cardiogenic shock (CS) who will require continuous infusion of Dobutamine and have developed sinus tachycardia (ST) (heart rate >100 beats/min).
The aim of the study will be to assess the potential of Ivabradine to slow ST and improve hemodynamics in patients with stage D HF/CS on Dobutamine treatment.
Detailed description
This study will explore the hypothesis that Ivabradine will decrease heart rate (HR) and improve hemodynamics in patients with advanced HF on inotropic treatment. This is a randomized, double blind, single center trial will include 40 consecutive patients admitted for Stage D HF/ CS who will require continuous infusion of Dobutamine and will develop ST (HR >100 beats/min).
Eligible patients will be randomized (1:1) using blocked randomization with random block sizes of 2 or 4 to start Ivabradine versus placebo. The procedure of randomization to receive either Ivabradine or placebo twice daily will be performed by computerized sequence generation. The hospital pharmacies will be responsible for drug randomization and dispensing, and the investigators and the patients will be blinded to the treatment option.
Ivabradine will be started 3 hours after Dobutamine initiation at dose 5 mg and further increased in 12 hours to 7.5 mg bid if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm. Increase of Ivabradine dosage will be individually stopped for reasons of safety if three episodes of minimal HRs of less than 70 beats per minute, or a drop in mean blood pressure < 60 mmHg or systolic blood pressure < 80 mmHg occur.
HR, blood pressure and invasive hemodynamics will be monitored, along with standard right heart cath and echocardiogram measurements obtained.
Patients will be followed for a total of 72 hours. The adverse events that will be collected include bradycardia, defined as a heart rate less than 70 bpm, hypotension defined as a systolic blood pressure less than 80 mmHg and any side effect requiring drug discontinuation or dose adjustment. Review of laboratory including renal, hepatic and hematologic counts will be reviewed for any significant changes due to the use of Ivabradine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double Blind, Placebo Controlled single center study.
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Active comparator | Drug: IvabradineInitiation at dose 5 mg PO x 1 dose and further increased in 12 hours to 7.5 mg PO twice per day if patient is stable with mean BP≥ 60 mmHg, systolic blood pressure ≥ 90 mmHg and HR ≥100 bpm |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo given PO twice per day |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provide written informed consent for the study
- Have current diagnosis of Ischemic and/or non-ischemic cardiomyopathy
- Left ventricular ejection fraction (LVEF) < 30% by echo during the screening
- Sinus rhythm with HR ≥100 bpm
- Systolic blood pressure ≥ 90 mmHg assessed by cuff sphygmomanometer
Key exclusion criteria (15 listed)
- Respiratory support with mechanical ventilation
- Circulatory mechanical support
- Atrial pacing with the presence of sick sinus syndrome or sino-atrial block
- Second or third degree atrioventricular (AV) block,
- Atrial fibrillation/flutter
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 |
|---|---|---|
| IvabradineAlso: Corlanorivabradine or placebo given orally 2 times daily for 72 hours | Drug | Ivabradine |
| Placebomatching placebo given 2 times daily for 72 hours | Drug | Placebo |
Primary outcome
Heart rate
Time frame: 72 hours
Heart rate will be measured and any changes noted
2 secondary outcomes
cardiac index
Time frame: 72 hours
plasma brain natriuretic peptide (BNP) level
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Background: PubMed 18250279Reynolds HR, Hochman JS. Cardiogenic shock: current concepts and improving outcomes. Circulation. 2008 Feb 5;117(5):686-97. doi: 10.1161/CIRCULATIONAHA.106.613596. No abstract available.
- Background: PubMed 15135197Vasquez A, Kern KB, Hilwig RW, Heidenreich J, Berg RA, Ewy GA. Optimal dosing of dobutamine for treating post-resuscitation left ventricular dysfunction. Resuscitation. 2004 May;61(2):199-207. doi: 10.1016/j.resuscitation.2004.01.002.
- Background: PubMed 884803Leier CV, Webel J, Bush CA. The cardiovascular effects of the continuous infusion of dobutamine in patients with severe cardiac failure. Circulation. 1977 Sep;56(3):468-72. doi: 10.1161/01.cir.56.3.468.
- Background: PubMed 12383572Metra M, Nodari S, D'Aloia A, Muneretto C, Robertson AD, Bristow MR, Dei Cas L. Beta-blocker therapy influences the hemodynamic response to inotropic agents in patients with heart failure: a randomized comparison of dobutamine and enoximone before and after chronic treatment with metoprolol or carvedilol. J Am Coll Cardiol. 2002 Oct 2;40(7):1248-58. doi: 10.1016/s0735-1097(02)02134-4.
- Background: PubMed 8277087Wynsen JC, O'Brien PD, Warltier DC. Zatebradine, a specific bradycardic agent, enhances the positive inotropic actions of dobutamine in ischemic myocardium. J Am Coll Cardiol. 1994 Jan;23(1):233-41. doi: 10.1016/0735-1097(94)90526-6.
- Background: PubMed 8547205Aidonidis I, Brachmann J, Rizos I, Zacharoulis A, Stavridis I, Toutouzas P, Kubler W. Electropharmacology of the bradycardic agents alinidine and zatebradine (UL-FS 49) in a conscious canine ventricular arrhythmia model of permanent coronary artery occlusion. Cardiovasc Drugs Ther. 1995 Aug;9(4):555-63. doi: 10.1007/BF00878087.
- Background: PubMed 8982692Hettrick DA, Pagel PS, Lowe D, Tessmer JP, Warltier DC. Increases in inotropic state without change in heart rate: combined use of dobutamine and zatebradine in conscious dogs. Eur J Pharmacol. 1996 Dec 5;316(2-3):237-44. doi: 10.1016/s0014-2999(96)00688-7.
- Background: PubMed 9265927Neustein SM, Dimich I, Shiang H, Mezrow C. Role of zatebradine and propranolol in attenuation of tachycardia produced by dobutamine in pigs. Acta Anaesthesiol Scand. 1997 Aug;41(7):849-52. doi: 10.1111/j.1399-6576.1997.tb04799.x.
- Background: PubMed 19559207Zhang Y, Mazgalev TN. Cardiac vagal stimulation eliminates detrimental tachycardia effects of dobutamine used for inotropic support. Ann Thorac Surg. 2009 Jul;88(1):117-22. doi: 10.1016/j.athoracsur.2009.04.009.
- Background: PubMed 15301560DiFrancesco D, Camm JA. Heart rate lowering by specific and selective I(f) current inhibition with ivabradine: a new therapeutic perspective in cardiovascular disease. Drugs. 2004;64(16):1757-65. doi: 10.2165/00003495-200464160-00003.
- Background: PubMed 18757088Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.
- Background: PubMed 20801500Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Dubost-Brama A, Lerebours G, Tavazzi L; SHIFT Investigators. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010 Sep 11;376(9744):875-85. doi: 10.1016/S0140-6736(10)61198-1.
- article: Safety, tolerability and efficacy of ivabradine for control of sinus tachycardia in patients undergoing inotropic therapyLink provided by the sponsor.
- 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.
Eugenia Raichlin, MD principal investigator
Loyola University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivabradine in people with Heart Failure and Cardiogenic Shock, run by Loyola University at 1 site in United States.
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 15 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 23 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 1 site in United States. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eugenia Raichlin, MD (708 327-2738, Eugenia.Raichlin@lumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: 72 hours). 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 NCT03387605, which also lists 27 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 23 May 2019.