Congestive Heart FailureREVIVALNCT01369407
REGISTRY EVALUATION OF VITAL INFORMATION FOR VADs IN AMBULATORY LIFE
An observational study of Congestive Heart Failure, run by University of Michigan at 21 sites in United States.
Trial summary
REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Congestive Heart Failure
- How many people
- 400 participants
- Where
- 21 sitesUnited States
- Study dates
- Jul 2015to 29 Aug 2018
- How long will I take part?
- 2 Years
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical records should be reviewed to assess for potential enrollment into the REVIVE-IT Registry. Heart failure subjects that meet all criteria should be approached to consent for this study.
Who may be able to join
- Ambulatory.
- Chronic systolic heart failure ≥ 12 months.
- NYHA II - IV for at least 45 of the last 60 days.
- Last documented left ventricular ejection fraction ≤ 35% by any imaging modality.
- Age 18 - 80 years.
- Under the care of a cardiologist at study site.
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- On appropriate evidenced -based heart failure medications - ACE inhibitor, ARB or sacubitril/valsartan [LCZ-696]; beta blocker; aldosterone antagonist; hydralazine/long-acting nitrate [required of African-American subjects only] for ≥ 3 months absent contraindications or intolerances.
- Has ICD or CRT-D. If CRT-D, present for ≥ 3 months.
- Demonstrated advanced heart failure, including any one of the following*:
- Serum sodium ≤ 135 mEq/L (obtained as an outpatient) ii. Serum BNP ≥ 750 pg/mL or NT-proBNP ≥ 3000 pg/mL (obtained as an outpatient) iii. Seattle Heart Failure Model (SHFM) one year predicted survival ≤ 85% iv. Heart Failure Survival Score (HFSS) ≤ 7.19 v. Peak VO2 ≤ 55% of predicted for age by Wasserman equation or ≤ 14 ml/kg/min, with RER ≥ 1.05* vi. VE/VC02 slope > 40* vii. 6 minute walk test (6MWT) distance ≤ 350 m without significant non-cardiac limitation** viii. Currently listed as Heart Transplant Status II due to heart failure limitation
- Or
- History of one (1) hospitalization (≥ 24 hours) for acute or acute on chronic heart failure in the past year with additional history to include:
- Serum BNP ≥ 500 pg/mL or NT-proBNP ≥ 2000 pg/mL** (obtained as an outpatient)
- Or
- History of two (2) hospitalizations (≥ 24 hours) for acute or acute on chronic heart failure in the past year.
- Qualifying measure must be the most recent of that type of measure obtained (i.e., a BNP ≥ 1000 obtained 2 months prior would not qualify the heart failure subject if a more recent BNP was < 1000)
- Using values obtained within the prior 90 days, except for peak VO2 within 365 days
- Obtained within the prior 365 days
- Willingness to continue to receive heart failure care from the enrolling advanced heart failure clinic over the next two (2) years and to come for all scheduled study visits.
- 12. Written Informed consent given.
Who cannot join
- Known serious medical problem other than heart failure that would be expected to limit 2-year survival (≥50% mortality within 2 years from non-heart failure diagnosis).
- Patient is not likely to be compliant with the protocol, in the opinion of the Investigator.
- Currently hospitalized.
- Current use of an intravenous inotrope.
- Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival.
- Chronic hemodialysis or peritoneal dialysis or a serum creatinine value of ≥ 3 mg/dL at time of enrollment.
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- Cardiac amyloidosis, cardiac sarcoidosis, constrictive pericardial disease, active myocarditis or congenital heart disease with significant structural abnormality.
- Hypertrophic cardiomyopathy unless dilated LV and no outflow gradient.
- Cardiac conditions that are amenable to surgical or percutaneous procedures (other than VAD or transplant) that would substantially improve prognosis and for which this subject is a reasonable candidate, regardless of whether the procedure will or will not be performed.
- Uncorrected hyperthyroidism or hypothyroidism.
- Pregnancy.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Abington Jefferson Health
Abington, Pennsylvania, 19001
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado, Denver
Aurora, Colorado, 80045
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Cedars-Sinai Medical Care Foundation
Beverly Hills, California, 90211
University of Alabama
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
UT Southwestern
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
Houston Methodist Hospital
Houston, Texas, 77030
Mount Sinai Hospital
New York, New York, 10029
INTEGRIS
Oklahoma City, Oklahoma, 73112
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University
Richmond, Virginia, 23298
University of Utah
Salt Lake City, Utah, 84132
Washington University, St. Louis
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: REVIVE-IT Registry (REVIVAL: Registry Evaluation of Vital Information For VADs in Ambulatory Life)
REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical risk measures are related to prognosis.
Read the detailed description
REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical risk measures are related to prognosis. Within the broader goal of 1) improving prognostic assessment in chronic, ambulatory, advanced systolic heart failure, additional targeted goals are to 2) better inform the selection of appropriate candidates for a future study of a strategy of early LVAD therapy vs. optimal medical management in this population, and 3) determine the feasibility of identifying candidates for such a trial. Therefore, the target population will have known high-risk features for increased mortality and hospitalization (e.g., frequent hospitalization, reduced exercise capacity, elevated BNP or N-terminal proBNP, increased Seattle Heart Failure Model risk score, reduced Heart Failure Survival Score).
The REVIVE-IT Registry (i.e., REVIVAL) is a prospective cohort study to be conducted in up to twenty five (25) participating Clinical Sites in the USA. The study will continue until up to 400 eligible heart failure heart failure subjects have been enrolled (estimated length of accrual is 12 months).
- Conditions
- Congestive Heart Failure
- Being tested
- No Intervention
- Keywords
- Heart failure, HF, Heart Diseases, Cardiovascular Diseases, Heart Failure NYHA class III, Advanced heart failure, Systolic Heart Failure
- Medical subject headings
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Heart Failure, Systolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Not an interventional study
| Study group | Role | What they receive |
|---|---|---|
| Enrolled Subjects | Enrolled subjects participate for up to 2 years Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize clinical outcomes, quality of life and functional impairment over two (2) years in a population of ambulatory patients on evidence-based therapy with advanced chronic systolic heart failure who may benefit from VAD therapy
Measured: 2 years
To evaluate the relationship between heart failure subject's modeled prognosis, self assessed prognosis, preferences for end of life care and thresholds for considering VAD implant.
Measured: 2 years
To evaluate caregiver burden associated with heart failure subject's measures of heart failure severity, quality of life, functional limitations and with preferences for care and thresholds for considering device implant.
Measured: 2 years.
To determine health-associated costs for heart failure subjects in the registry.
Measured: 2 years.
To provide the REVIVE-IT Registry to the INTERMACS study group to be used in comparative analyses of outcomes of patients treated with medical versus VAD therapy.
Measured: 2 years.
Secondary outcomes (5)
Hospitalization
Assessed throughout participation
Measured: 2 years
Stroke
Assessed throughout participation
Measured: 2 years
MCSD
Assessed throughout participation (study endpoint)
Measured: 2 years
Transplant
Assessed throughout participation (study endpoint)
Measured: 2 years
Death
Assessed throughout participation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJul 2015
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Aaronson, University of Michigan
- Investigators
- Keith Aaronson, MD, MS, Principal investigator, University of MichiganGarrick Stewart, MD, Principal investigator, Brigham and Women's HospitalDoug Mann, MD, Study chair, University of Washington - St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369407
- Sponsor's protocol ID
- REVIVE-IT REGISTRY (REVIVAL)
- Other IDs
- HHSN268201100026C
- Acronym
- REVIVAL
- Status last verified
- Sep 2018
- First submitted
- 1 Jun 2011
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Aaronson KD, Stewart GC, Stevenson LW, Richards B, Khalatbari S, Cascino TC, Ambardekar AV, Stehlik J, Lala A, Kittleson MM, Palardy M, Mountis MM, Pagani FD, Jeffries N, Taddei-Peters WC, Mann DL; REVIVAL Investigators. Optimizing Triage of Ambulatory Patients With Advanced Heart Failure: 2-Year Outcomes From REVIVAL. JACC Heart Fail. 2024 Oct;12(10):1734-1746. doi: 10.1016/j.jchf.2024.05.008. Epub 2024 Jul 3.
PubMed 38970587Cascino TM, Colvin MM, Lanfear DE, Richards B, Khalatbari S, Mann DL, Taddei-Peters WC, Jeffries N, Watkins DC, Stewart GC, Aaronson KD; REVIVAL Investigators. Racial Inequities in Access to Ventricular Assist Device and Transplant Persist After Consideration for Preferences for Care: A Report From the REVIVAL Study. Circ Heart Fail. 2023 Jan;16(1):e009745. doi: 10.1161/CIRCHEARTFAILURE.122.009745. Epub 2022 Oct 19.
PubMed 36259388Lala A, Shah KB, Lanfear DE, Thibodeau JT, Palardy M, Ambardekar AV, McNamara DM, Taddei-Peters WC, Baldwin JT, Jeffries N, Khalatbari S, Spino C, Richards B, Mann DL, Stewart GC, Aaronson KD, Mancini DM; REVIVAL Investigators. Predictive Value of Cardiopulmonary Exercise Testing Parameters in Ambulatory Advanced Heart Failure. JACC Heart Fail. 2021 Mar;9(3):226-236. doi: 10.1016/j.jchf.2020.11.008. Epub 2021 Feb 3.
PubMed 33549559Cascino TM, Kittleson MM, Lala A, Stehlik J, Palardy M, Pamboukian SV, Ewald GA, Mountis MM, Horstmanshof DA, Robinson SW, Shah P, Jorde UP, McLean RC, Richards B, Khalatbari S, Spino C, Taddei-Peters WC, Grady KL, Mann DL, Stevenson LW, Stewart GC, Aaronson KD; REVIVAL Investigators. Comorbid Conditions and Health-Related Quality of Life in Ambulatory Heart Failure Patients: REVIVAL (Registry Evaluation of Vital Information for VADs in Ambulatory Life REVIVAL). Circ Heart Fail. 2020 May;13(5):e006858. doi: 10.1161/CIRCHEARTFAILURE.119.006858. Epub 2020 May 18.
PubMed 32418478Pagani FD, Aaronson KD, Kormos R, Mann DL, Spino C, Jeffries N, Taddei-Peters WC, Mancini DM, McNamara DM, Grady KL, Gorcsan J 3rd, Petrucci R, Anderson AS, Glick HA, Acker MA, Eduardo Rame J, Goldstein DJ, Pamboukian SV, Miller MA, Timothy Baldwin J; REVIVE-IT Investigators. The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy. J Heart Lung Transplant. 2016 Nov;35(11):1277-1283. doi: 10.1016/j.healun.2016.09.002. Epub 2016 Oct 6.
PubMed 27836022
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVIVE-IT Registry (REVIVAL: Registry Evaluation of Vital Information For VADs in Ambulatory Life)
- ClinicalTrials.gov ID
- NCT01369407
- Acronym / sponsor ID
- REVIVAL / REVIVE-IT REGISTRY (REVIVAL)
- Conditions
- Congestive Heart Failure
- Keywords
- Heart failure, HF, Heart Diseases, Cardiovascular Diseases, Heart Failure NYHA class III, Advanced heart failure, Systolic Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Brigham and Women's Hospital
- Study start
- Jul 2015 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 8 Jun 2011 (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.
REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical risk measures are related to prognosis.
Detailed description
REVIVAL will establish a prospective, observational, multicenter patient cohort in ambulatory patients with chronic, advanced, systolic heart failure that will provide a greater understanding of their clinical trajectory (rates of hospitalizations, transplantation, MCSD use and death), and of how baseline clinical risk measures are related to prognosis. Within the broader goal of 1) improving prognostic assessment in chronic, ambulatory, advanced systolic heart failure, additional targeted goals are to 2) better inform the selection of appropriate candidates for a future study of a strategy of early LVAD therapy vs. optimal medical management in this population, and 3) determine the feasibility of identifying candidates for such a trial. Therefore, the target population will have known high-risk features for increased mortality and hospitalization (e.g., frequent hospitalization, reduced exercise capacity, elevated BNP or N-terminal proBNP, increased Seattle Heart Failure Model risk score, reduced Heart Failure Survival Score).
The REVIVE-IT Registry (i.e., REVIVAL) is a prospective cohort study to be conducted in up to twenty five (25) participating Clinical Sites in the USA. The study will continue until up to 400 eligible heart failure heart failure subjects have been enrolled (estimated length of accrual is 12 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrolled Subjects | – | Other: No InterventionEnrolled subjects participate for up to 2 years |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical records should be reviewed to assess for potential enrollment into the REVIVE-IT Registry. Heart failure subjects that meet all criteria should be approached to consent for this study.
Key inclusion criteria (20 listed)
- Ambulatory.
- Chronic systolic heart failure ≥ 12 months.
- NYHA II - IV for at least 45 of the last 60 days.
- Last documented left ventricular ejection fraction ≤ 35% by any imaging modality.
- Age 18 - 80 years.
Key exclusion criteria (11 listed)
- Known serious medical problem other than heart failure that would be expected to limit 2-year survival (≥50% mortality within 2 years from non-heart failure diagnosis).
- Patient is not likely to be compliant with the protocol, in the opinion of the Investigator.
- Currently hospitalized.
- Current use of an intravenous inotrope.
- Primary functional limitation from non-cardiac diagnosis even if not likely to limit survival.
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 |
|---|---|---|
| No InterventionNot an interventional study | Other | Enrolled Subjects |
Primary outcome
To characterize clinical outcomes, quality of life and functional impairment over two (2) years in a population of ambulatory patients on evidence-based therapy with advanced chronic systolic heart failure who may benefit from VAD therapy
Time frame: 2 years
To evaluate the relationship between heart failure subject's modeled prognosis, self assessed prognosis, preferences for end of life care and thresholds for considering VAD implant.
Time frame: 2 years
To evaluate caregiver burden associated with heart failure subject's measures of heart failure severity, quality of life, functional limitations and with preferences for care and thresholds for considering device implant.
Time frame: 2 years.
To determine health-associated costs for heart failure subjects in the registry.
Time frame: 2 years.
To provide the REVIVE-IT Registry to the INTERMACS study group to be used in comparative analyses of outcomes of patients treated with medical versus VAD therapy.
Time frame: 2 years.
5 secondary outcomes
Hospitalization
Time frame: 2 years
Stroke
Time frame: 2 years
MCSD
Time frame: 2 years
Transplant
Time frame: 2 years
Death
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Derived from this study: PubMed 38970587Aaronson KD, Stewart GC, Stevenson LW, Richards B, Khalatbari S, Cascino TC, Ambardekar AV, Stehlik J, Lala A, Kittleson MM, Palardy M, Mountis MM, Pagani FD, Jeffries N, Taddei-Peters WC, Mann DL; REVIVAL Investigators. Optimizing Triage of Ambulatory Patients With Advanced Heart Failure: 2-Year Outcomes From REVIVAL. JACC Heart Fail. 2024 Oct;12(10):1734-1746. doi: 10.1016/j.jchf.2024.05.008. Epub 2024 Jul 3.
- Derived from this study: PubMed 36259388Cascino TM, Colvin MM, Lanfear DE, Richards B, Khalatbari S, Mann DL, Taddei-Peters WC, Jeffries N, Watkins DC, Stewart GC, Aaronson KD; REVIVAL Investigators. Racial Inequities in Access to Ventricular Assist Device and Transplant Persist After Consideration for Preferences for Care: A Report From the REVIVAL Study. Circ Heart Fail. 2023 Jan;16(1):e009745. doi: 10.1161/CIRCHEARTFAILURE.122.009745. Epub 2022 Oct 19.
- Derived from this study: PubMed 33549559Lala A, Shah KB, Lanfear DE, Thibodeau JT, Palardy M, Ambardekar AV, McNamara DM, Taddei-Peters WC, Baldwin JT, Jeffries N, Khalatbari S, Spino C, Richards B, Mann DL, Stewart GC, Aaronson KD, Mancini DM; REVIVAL Investigators. Predictive Value of Cardiopulmonary Exercise Testing Parameters in Ambulatory Advanced Heart Failure. JACC Heart Fail. 2021 Mar;9(3):226-236. doi: 10.1016/j.jchf.2020.11.008. Epub 2021 Feb 3.
- Derived from this study: PubMed 32418478Cascino TM, Kittleson MM, Lala A, Stehlik J, Palardy M, Pamboukian SV, Ewald GA, Mountis MM, Horstmanshof DA, Robinson SW, Shah P, Jorde UP, McLean RC, Richards B, Khalatbari S, Spino C, Taddei-Peters WC, Grady KL, Mann DL, Stevenson LW, Stewart GC, Aaronson KD; REVIVAL Investigators. Comorbid Conditions and Health-Related Quality of Life in Ambulatory Heart Failure Patients: REVIVAL (Registry Evaluation of Vital Information for VADs in Ambulatory Life REVIVAL). Circ Heart Fail. 2020 May;13(5):e006858. doi: 10.1161/CIRCHEARTFAILURE.119.006858. Epub 2020 May 18.
- Derived from this study: PubMed 27836022Pagani FD, Aaronson KD, Kormos R, Mann DL, Spino C, Jeffries N, Taddei-Peters WC, Mancini DM, McNamara DM, Grady KL, Gorcsan J 3rd, Petrucci R, Anderson AS, Glick HA, Acker MA, Eduardo Rame J, Goldstein DJ, Pamboukian SV, Miller MA, Timothy Baldwin J; REVIVE-IT Investigators. The NHLBI REVIVE-IT study: Understanding its discontinuation in the context of current left ventricular assist device therapy. J Heart Lung Transplant. 2016 Nov;35(11):1277-1283. doi: 10.1016/j.healun.2016.09.002. Epub 2016 Oct 6.
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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.
Keith Aaronson, MD, MS principal investigator
University of Michigan
Garrick Stewart, MD principal investigator
Brigham and Women's Hospital
Doug Mann, MD study chair
University of Washington - St. Louis
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by University of Michigan at 21 sites 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 20 inclusion and 11 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To characterize clinical outcomes, quality of life and functional impairment over two (2) years in a population of ambulatory patients on evidence-based therapy with advanced chronic systolic heart failure who may benefit from VAD therapy (time frame: 2 years). The study lists 5 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 NCT01369407, which also lists 5 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 7 Sep 2018.