Acute Heart FailurePhase 3B-AHEFNCT01822808
Bi Treatment With Hydralazine/Nitrates Versus Placebo in Africans Admitted With Acute Heart Failure
A Phase 3 study testing Hydralazine and Isosorbide Dinitrate in people with Acute Heart Failure and Left Ventricular Dysfunction, run by University of Cape Town at 1 site in South Africa.
Trial summary
To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Left Ventricular Dysfunction
- What is being tested?
- Hydralazine and Isosorbide Dinitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jan 2013to Jul 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination.
- Where available, NT-proBNP >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if BMI > 35 kg/m2, LVEF <45% assessed by echocardiography or other method within the previous 12 months
- Background therapy with at least ACE-inhibitor or angiotensin receptor blocker (ARB) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock)
- Available for regular follow up
Who cannot join
- Currently being treated with Hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.
- . Any intravenous treatment for heart failure, except IV furosemide (eg. IV inotropes, pressors, nitrates or nesiritide) at the time of screening.
- Systolic blood pressure <100 mmHg
- Plan for revascularization
- Greater than 96 hours after admission
- Reversible etiology of acute heart failure such as myocarditis, acute myocardial infarction, arrhythmia. Acute MI is defined as symptoms and major electrocardiogram (ECG) changes(i.e., ST segment elevations), and arrhythmia includes unstable heart rates above 120/min or below 50/min.
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- Hypertrophic obstructive cardiomyopathy, constrictive cardiomyopathy, endomyocardial fibroelastosis
- Known severe congenital heart disease (such as uncorrected tetralogy of fallot or transposition of the aorta)
- Severe aortic or mitral stenosis or severe rheumatic mitral regurgitation.
- Renal impairment (defined by creatinine >3 mg/dL) at screening or on any type of dialysis.
- Known hepatic impairment (total bilirubin >3mg/dl) or increased ammonia levels at screening.
- History of systemic lupus erythematous.
- Stroke or TIA within 2 weeks from screening.
- Women who are pregnant or lactating.
- Allergy to organic nitrates.
- History or presence of any other diseases (ie. Including malignancies or AIDS) with a life expectancy of < 12 months
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Hatter Institute for Cardiovascular Research in Africa
Cape Town, Western Cape, 7925
About this study
Official title: A Prospective, Placebo-controlled, Double-blind, Randomized Study to Compare Hydralazine-isosorbide-dinitrate(HYIS) Versus Placebo on Top of Std Care in African Patients With Acute Heart Failure (AHF) and Left Ventricular Dysfunction
To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy.
Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.
Read the detailed description
Heart failure (HF) is a pathophysiologic condition and is a final common pathway of most forms of cardiovascular disease. Patients with HF experience poor quality of life, recurrent emergency hospitalizations and premature mortality.
Recent publications highlight the multiple challenges of dealing with an increasing burden of heart disease within an urban African community. The predominance of women and novel underlying causes contrast with the demographic of HF in high income countries. More than 50% of 5328 de novo cases of heart disease captured at a tertiary clinic in Soweto presented with some form of heart failure, mainly due to poorly treated hypertension, idiopathic dilated cardiomyopathy, peripartum cardiomyopathy and HIV-related cardiomyopathy. The most prevalent form of heart disease was hypertensive heart failure (> 1100 cases).
Programs have been developed in high income countries that cost-effectively prevent progressive cardiac dysfunction in high risk individuals and apply evidence-based treatments to optimize the overall management of HF. There is, however, a paucity of data describing the etiology and underlying cardiac structure and function, as well as contemporary management of HF in low to middle income countries.
In 2005 a number of leading clinicians from Africa and the US published a "call for action" highlighting the need for an African study documenting the aetiology of acute heart failure and the management practices applied to these patients. As a result, The Sub-Saharan Africa Survey of Heart Failure (THESUS HF) study, was initiated in 9 countries in Africa to determine aetiology, treatment, morbidity and mortality of acute heart failure (HF) in the African sub-continent. The data reported in this study are unique as they are the first larger outcome study in acute heart failure from this continent. This first multinational study of over 1000 patients with acute decompensated heart failure conducted in all regions of sub-Saharan Africa shows, for the first time, that the treatment of heart failure is sub-optimal in the region, with relatively low proven medical treatments (such as beta-blockers, hydralazine and nitrates) and inappropriately high use of aspirin in a cohort of patients with non-ischaemic heart failure. This study also had the clear purpose of enhancing research capacity in Africa via collaborative research as outlined in our publication.
The use of Ace inhibitors (ACEi) and hydralazine/nitrates has never been examined in patients admitted with acute heart failure. All studies demonstrating the beneficial effects of these drugs were performed in patients with chronic heart failure. Previous studies have shown that the administration of ACEi in African Americans with chronic heart failure is less effective and not superior to combined treatment with hydralazine/isosorbide dinitrate. The African American Heart Failure Trial (A-HeFT) established the benefit of adjunctive administration of isosorbide dinitrate/hydralazine (ISDN/HYD) in addition to standard therapy for African American patients with symptomatic heart failure. The risk of death was reduced by 33% and markers of quality of life were improved.
The THESUS registry has shown a high prevalence of hypertension with left ventricular systolic dysfunction (hypertensive heart failure) and dilated cardiomyopathy as a cause of acute heart failure in all participating African countries. Patients in Africa are rarely treated with this combination therapy as the fixed combination (Bidil) is unavailable in Africa. There is uncertainty if the combination of hydralazine and isosorbide dinitrate, available as generic agents, is beneficial in Africans and many physicians in Africa are not aware of the outcome of those studies published in high impact factor journals, often not available to local doctors.
Performing a multicentre study in Africa could confirm data obtained in African Americans, create awareness for this promising combination treatment and extend the use of the medication to patients with acute heart failure.
This BAHEF protocol has an approved 'Amendment # 1' dated 29 April 2013. Amendments were changes to the Eligibility criteria and have been changed on this site.
To date, 22 Sept 2014, the BAHEF study has enrolled 110 study subjects. To date, 13 Aug 2015, the BAHEF study has enrolled 145 eligible subjects.
- Conditions
- Acute Heart Failure, Left Ventricular Dysfunction
- Being tested
- Hydralazine, Isosorbide Dinitrate
- Keywords
- acute heart failure, left ventricular dysfunction, hydralazine, isosorbide dinitrate
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydralazineDrug
Also called Hyperphen
Hydralazine and placebo will be supplied as 25mg identical tablets and given at a dosage of 75mg/day up to week 4, thereafter 150mg/day up to week 24.
Isosorbide DinitrateDrug
Also called Isordil
Isosorbide dinitrate and placebo will be supplied as 10mg identical tablets and given at a dosage of 30mg/day up to week 4, thereafter 60mg/day up to week 24.
| Study group | Role | What they receive |
|---|---|---|
| Hydralazine | Active comparator | 24 week course of Hydralazine 25mg 3 times daily for 4 weeks, thereafter uptitrating to 50mg hydralazine 3 times daily up to week 24. Those assigned to the Hydralazine control arm will receive the same number of identical placebo tablets. Receives: Drug: Hydralazine |
| Isosorbide dinitrate | Active comparator | 24 week course of Isosorbide dinitrate 10mg 3 times daily for 4 weeks, thereafter uptitrating to 20mg isosorbide dinitrate 3 times daily up to week 24. Those assigned to the Isosorbide dinitrate control arm will receive the same number of identical placebo tablets. Receives: Drug: Isosorbide Dinitrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death or HF re-admission
In African patients admitted with acute heart failure, to investigate the effect of the combination of hydralazine/isosorbide dinitrate (HYIS) on the rate of death or re-admission for HF during 24 weeks of therapy
Measured: through to day 180
Secondary outcomes (5)
Change in symptoms of heart failure
Change in symptoms of HF from baseline to 7 days post randomization or discharge, as assessed by dyspnoea severity and global well being on a VAS scale
Measured: within 7 days post randomization
Change in systolic blood pressure
Change in systolic blood pressure from baseline to 7 days post randomization or discharge and at 8 weeks and 24 weeks post randomization
Measured: within 7 days post randomization
Functional status
Functional status assessed by 6 minute walk at 7 days post randomization or discharge, and at 8 weeks and 24 weeks post randomization
Measured: 7 days post randomization
Changes in serum creatinine
Changes in serum creatinine, blood urea nitrogen (BUN) and estimated glomerular filtration rate (eGFR) from baseline to 8 weeks post randomization and at 24 weeks post randomization
Measured: up to 8 weeks post randomization
Change in left ventricular dimensions
Change in left ventricular dimensions and left ventricular ejection fraction (LVEF) from baseline to 24 weeks post randomization.
Measured: up to 24 weeks post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Momentum Research, Inc.
- Responsible party
- Principal investigator, Prof. Karen Sliwa, University of Cape Town
- Investigators
- Karen Sliwa, PhD, Principal investigator, Hatter Institute for Cardiovascular Research In Africa (HICRA), University of Cape TownGad Cotter, MD, Study director, Momentum Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01822808
- Sponsor's protocol ID
- B-AHEF
- Acronym
- B-AHEF
- Status last verified
- Aug 2015
- First submitted
- 25 Mar 2013
- Last updated
- 14 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sani MU, Damasceno A, Davison BA, Cotter G, Mayosi BM, Edwards C, Azibani F, Adam T, Arif G, Jessen N, Sliwa K. N-terminal pro BNP and galectin-3 are prognostic biomarkers of acute heart failure in sub-Saharan Africa: lessons from the BAHEF trial. ESC Heart Fail. 2021 Feb;8(1):74-84. doi: 10.1002/ehf2.13032. Epub 2020 Nov 28.
PubMed 33247624Sliwa K, Damasceno A, Davison BA, Mayosi BM, Sani MU, Ogah O, Mondo C, Ojji D, Dzudie A, Kouam CK, Yonga G, Ba SA, Ogola E, Edwards C, Milo O, Cotter G. Bi treatment with hydralazine/nitrates vs. placebo in Africans admitted with acute HEart Failure (BA-HEF). Eur J Heart Fail. 2016 Oct;18(10):1248-1258. doi: 10.1002/ejhf.581. Epub 2016 May 20.
PubMed 27206810
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Placebo-controlled, Double-blind, Randomized Study to Compare Hydralazine-isosorbide-dinitrate(HYIS) Versus Placebo on Top of Std Care in African Patients With Acute Heart Failure (AHF) and Left Ventricular Dysfunction
- ClinicalTrials.gov ID
- NCT01822808
- Acronym / sponsor ID
- B-AHEF / B-AHEF
- Conditions
- Acute Heart Failure, Left Ventricular Dysfunction
- Keywords
- acute heart failure, left ventricular dysfunction, hydralazine, isosorbide dinitrate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Momentum Research, Inc.
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 2 Apr 2013 (estimated)
- 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.
To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy.
Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction.
Detailed description
Heart failure (HF) is a pathophysiologic condition and is a final common pathway of most forms of cardiovascular disease. Patients with HF experience poor quality of life, recurrent emergency hospitalizations and premature mortality.
Recent publications highlight the multiple challenges of dealing with an increasing burden of heart disease within an urban African community. The predominance of women and novel underlying causes contrast with the demographic of HF in high income countries. More than 50% of 5328 de novo cases of heart disease captured at a tertiary clinic in Soweto presented with some form of heart failure, mainly due to poorly treated hypertension, idiopathic dilated cardiomyopathy, peripartum cardiomyopathy and HIV-related cardiomyopathy. The most prevalent form of heart disease was hypertensive heart failure (> 1100 cases).
Programs have been developed in high income countries that cost-effectively prevent progressive cardiac dysfunction in high risk individuals and apply evidence-based treatments to optimize the overall management of HF. There is, however, a paucity of data describing the etiology and underlying cardiac structure and function, as well as contemporary management of HF in low to middle income countries.
In 2005 a number of leading clinicians from Africa and the US published a "call for action" highlighting the need for an African study documenting the aetiology of acute heart failure and the management practices applied to these patients. As a result, The Sub-Saharan Africa Survey of Heart Failure (THESUS HF) study, was initiated in 9 countries in Africa to determine aetiology, treatment, morbidity and mortality of acute heart failure (HF) in the African sub-continent. The data reported in this study are unique as they are the first larger outcome study in acute heart failure from this continent. This first multinational study of over 1000 patients with acute decompensated heart failure conducted in all regions of sub-Saharan Africa shows, for the first time, that the treatment of heart failure is sub-optimal in the region, with relatively low proven medical treatments (such as beta-blockers, hydralazine and nitrates) and inappropriately high use of aspirin in a cohort of patients with non-ischaemic heart failure. This study also had the clear purpose of enhancing research capacity in Africa via collaborative research as outlined in our publication.
The use of Ace inhibitors (ACEi) and hydralazine/nitrates has never been examined in patients admitted with acute heart failure. All studies demonstrating the beneficial effects of these drugs were performed in patients with chronic heart failure. Previous studies have shown that the administration of ACEi in African Americans with chronic heart failure is less effective and not superior to combined treatment with hydralazine/isosorbide dinitrate. The African American Heart Failure Trial (A-HeFT) established the benefit of adjunctive administration of isosorbide dinitrate/hydralazine (ISDN/HYD) in addition to standard therapy for African American patients with symptomatic heart failure. The risk of death was reduced by 33% and markers of quality of life were improved.
The THESUS registry has shown a high prevalence of hypertension with left ventricular systolic dysfunction (hypertensive heart failure) and dilated cardiomyopathy as a cause of acute heart failure in all participating African countries. Patients in Africa are rarely treated with this combination therapy as the fixed combination (Bidil) is unavailable in Africa. There is uncertainty if the combination of hydralazine and isosorbide dinitrate, available as generic agents, is beneficial in Africans and many physicians in Africa are not aware of the outcome of those studies published in high impact factor journals, often not available to local doctors.
Performing a multicentre study in Africa could confirm data obtained in African Americans, create awareness for this promising combination treatment and extend the use of the medication to patients with acute heart failure.
This BAHEF protocol has an approved 'Amendment # 1' dated 29 April 2013. Amendments were changes to the Eligibility criteria and have been changed on this site.
To date, 22 Sept 2014, the BAHEF study has enrolled 110 study subjects. To date, 13 Aug 2015, the BAHEF study has enrolled 145 eligible subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydralazine | Active comparator | Drug: Hydralazine24 week course of Hydralazine 25mg 3 times daily for 4 weeks, thereafter uptitrating to 50mg hydralazine 3 times daily up to week 24. Those assigned to the Hydralazine control arm will receive the same number of identical placebo tablets. |
| Isosorbide dinitrate | Active comparator | Drug: Isosorbide Dinitrate24 week course of Isosorbide dinitrate 10mg 3 times daily for 4 weeks, thereafter uptitrating to 20mg isosorbide dinitrate 3 times daily up to week 24. Those assigned to the Isosorbide dinitrate control arm will receive the same number of identical placebo tablets. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- > 18 years of age
- Hospital admission for acute heart failure as defined by the presence of acute dyspnea and the presence of clinical signs of heart failure on physical examination.
- Where available, NT-proBNP >900 pg/ml, >1800 pg/ml if the patient has atrial fibrillation at screening or >450 pg/ml if BMI > 35 kg/m2, LVEF <45% assessed by echocardiography or other method within the previous 12 months
- Background therapy with at least ACE-inhibitor or angiotensin receptor blocker (ARB) and beta-blocker (unless beta-blocker is contraindicated due to severe volume overload, low output heart failure, or cardiogenic shock)
- Available for regular follow up
Key exclusion criteria (16 listed)
- Currently being treated with Hydralazine and/or nitrates or a history of intolerance to oral therapy with either hydralazine or nitrates.
- . Any intravenous treatment for heart failure, except IV furosemide (eg. IV inotropes, pressors, nitrates or nesiritide) at the time of screening.
- Systolic blood pressure <100 mmHg
- Plan for revascularization
- Greater than 96 hours after admission
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 |
|---|---|---|
| HydralazineAlso: HyperphenHydralazine and placebo will be supplied as 25mg identical tablets and given at a dosage of 75mg/day up to week 4, thereafter 150mg/day up to week 24. | Drug | Hydralazine |
| Isosorbide DinitrateAlso: IsordilIsosorbide dinitrate and placebo will be supplied as 10mg identical tablets and given at a dosage of 30mg/day up to week 4, thereafter 60mg/day up to week 24. | Drug | Isosorbide dinitrate |
Primary outcome
Time to death or HF re-admission
Time frame: through to day 180
In African patients admitted with acute heart failure, to investigate the effect of the combination of hydralazine/isosorbide dinitrate (HYIS) on the rate of death or re-admission for HF during 24 weeks of therapy
5 secondary outcomes
Change in symptoms of heart failure
Time frame: within 7 days post randomization
Change in systolic blood pressure
Time frame: within 7 days post randomization
Functional status
Time frame: 7 days post randomization
Changes in serum creatinine
Time frame: up to 8 weeks post randomization
Change in left ventricular dimensions
Time frame: up to 24 weeks post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2015.
- Derived from this study: PubMed 33247624Sani MU, Damasceno A, Davison BA, Cotter G, Mayosi BM, Edwards C, Azibani F, Adam T, Arif G, Jessen N, Sliwa K. N-terminal pro BNP and galectin-3 are prognostic biomarkers of acute heart failure in sub-Saharan Africa: lessons from the BAHEF trial. ESC Heart Fail. 2021 Feb;8(1):74-84. doi: 10.1002/ehf2.13032. Epub 2020 Nov 28.
- Derived from this study: PubMed 27206810Sliwa K, Damasceno A, Davison BA, Mayosi BM, Sani MU, Ogah O, Mondo C, Ojji D, Dzudie A, Kouam CK, Yonga G, Ba SA, Ogola E, Edwards C, Milo O, Cotter G. Bi treatment with hydralazine/nitrates vs. placebo in Africans admitted with acute HEart Failure (BA-HEF). Eur J Heart Fail. 2016 Oct;18(10):1248-1258. doi: 10.1002/ejhf.581. Epub 2016 May 20.
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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.
Karen Sliwa, PhD principal investigator
Hatter Institute for Cardiovascular Research In Africa (HICRA), University of Cape Town
Gad Cotter, MD study director
Momentum Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydralazine and Isosorbide Dinitrate in people with Acute Heart Failure and Left Ventricular Dysfunction, run by University of Cape Town at 1 site in South Africa.
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 16 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 14 Aug 2015. 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 South Africa. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
Time to death or HF re-admission (time frame: through to day 180). 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 NCT01822808, 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 14 Aug 2015.