Heart Failure Risk Factors in Healthy IndividualsCHAMPSNCT03012022
Cleveland Heart and Metabolic Prevention Study
An observational study of Heart Failure Risk Factors in Healthy Individuals, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the role of chemical reactions, such as inflammation and oxidation, in the cause of cardiac dysfunction (the heart does not function properly). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure Risk Factors in Healthy Individuals
- How many people
- 1,208 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2010to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Either age 40 years or older OR age 18 years or older with a family history of heart failure or cardiac dysfunction (the heart does not function properly).
- Able and willing to consent to the study protocol, including an overnight (≥10 hour) fast.
Who cannot join
- Known history of heart failure or cardiomyopathy (LVSD, defined by left ventricular ejection fraction ≤45%) at the time of enrollment
- Major cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism), or major surgery <1 month of enrollment of present study (subject can be considered enrollment after 1 month if deemed clinically stable)
- Any hospitalization or emergency room visits for any cause <1 month of enrollment present study
- Known life expectancy <6 months at the time of enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nitrative Stress in Heart Failure: The Cleveland Heart and Metabolic Prevention Study (CHAMPS)
The purpose of this research study is to investigate the role of chemical reactions, such as inflammation and oxidation, in the cause of cardiac dysfunction (the heart does not function properly). The investigators are interested in studying the various chemical pathways for cell damage to determine which are the most prevalent and/or most important. The investigators also want to determine whether waste products of oxidative damage or other chemicals can be monitored in the blood or urine and serve as an indication of the existence and severity of overall heart disease activity. The investigators further want to determine whether certain proteins, called enzymes, affect this cell damage, or whether the presence or absence of certain genes which create different forms of these enzymes correlate with the development of heart failure or cardiomyopathy (weakening of the heart muscle or a change in heart muscle structure) or other cardiovascular diseases.
Read the detailed description
This is a single-center study conducted at the Cleveland Clinic. The target population for this study is very broad and goes beyond any specific cohort or community. Participants will be mainly recruited from the greater Cleveland/Akron area, but any volunteer meeting the inclusion/exclusion criteria is eligible for participation.
The overall goal of the Cleveland Heart And Metabolic Prevention Study (CHAMPS) is to determine the role of nitrative stress in the development and progression of heart failure (HF) and left ventricular systolic dysfunction (LVSD). The investigators have previously developed and performed preliminary clinical validation studies on multiple specific molecular footprints of known pathways of nitric oxide (NO) pathobiology that affect substrate availability for NO production or generation of NO-derived oxidants as a result of nitrative stress. For each these molecular markers and indices, mechanistic links to cardiovascular diseases have been demonstrated. However, these processes may be differentially expressed in different proportions at different stages of LVSD/HF disease progression, and certainly may vary among different individuals. It is the investigators' hypothesis that the interplay of many of these processes contribute to development of subclinical myocardial dysfunction (SMD), and the progression to overt LVSD and HF.
In order to help determine the role of nitrative stress in the development and progression of heart failure and left ventricular systolic dysfunction study participants will receive many non-invasive, research only, procedures as well as a blood draw and urine collection. The procedures performed may include electrocardiogram (ECG), echocardiogram, carotid intima-medial thickness measurements, ankle-brachial index, bioelectrical impedance analysis, pulse wave velocity analysis, spirometry, exhaled nitric oxide analysis, and venous occlusion strain-gauge plethysmography. The specific tests performed on each participant will be at the description of the primary investigator and not all participants will receive all tests. All participants will have blood and urine collections and all participants will be asked to fill out questionnaires pertaining to family history, personal medical history and estimates of functional capacity.
Specific aims include:
Aim 1: To test the hypothesis that levels of specific nitric oxide (NO)-mediated processes are associated with the presence of SMD and LVSD/HF.
Aim 2: To test the hypothesis that levels of specific NO-mediated processes are associated with prospective risks for development of adverse cardiovascular events and overt HF in stable patients without LVSD/HF at baseline.
- Keywords
- Healthy Volunteers, Congestive Heart Failure, Cardiomyopathies, Heart Failure, Risk Factors
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Volunteers without known cardiomyopathy or heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between metabolic and/or nitrative stress markers and predefined clinical endpoints
Clinical endpoints include acute myocardial infarction, acute coronary syndrome, congestive heart failure, serious cardiac arrhythmia, peripheral vascular disease, cerebrovascular events and death. Events will be aggregated into a common category (e.g. MACE) for statistical analysis and reporting. These aggregated events data will then be correlated with each biomarker of interest.
Measured: 10 years
Secondary outcomes (5)
Determination of sub-clinical myocardial dysfunction by echocardiogram
Determination of sub-clinical myocardial dysfunction by echocardiogram
Measured: 10 years
Correlation between DASI functional capacity and markers of metabolic and nitrative stress
Correlation between functional capacity, as measured by the Duke Activity Status Index (DASI) questionnaire, and markers of metabolic and nitrative stress
Measured: 10 years
Correlation between SF36 functional capacity and markers of metabolic and nitrative stress
Correlation between functional capacity, as measured by the SF36 version 2 questionnaire, and markers of metabolic and nitrative stress
Measured: 10 years
Correlation between DASI functional capacity and markers of cardiac dysfunction
Correlation between functional capacity, as measured by DASI questionnaire, and markers of cardiac dysfunction
Measured: 10 years
Correlation between SF36 functional capacity and markers of cardiac dysfunction
Correlation between functional capacity, as measured by SF36 version 2 questionnaire, and markers of cardiac dysfunction
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start8 Nov 2010
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Heart Failure Risk Factors in Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,208 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Wilson Tang, The Cleveland Clinic
- Investigators
- W. H. Wilson Tang, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012022
- Sponsor's protocol ID
- 10-727
- Other IDs
- 1R01HL103931
- Acronym
- CHAMPS
- Status last verified
- Jun 2026
- First submitted
- 15 Dec 2016
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abu-Soud HM, Hazen SL. Nitric oxide is a physiological substrate for mammalian peroxidases. J Biol Chem. 2000 Dec 1;275(48):37524-32. doi: 10.1074/jbc.275.48.37524.
PubMed 11090610Shiva S, Wang X, Ringwood LA, Xu X, Yuditskaya S, Annavajjhala V, Miyajima H, Hogg N, Harris ZL, Gladwin MT. Ceruloplasmin is a NO oxidase and nitrite synthase that determines endocrine NO homeostasis. Nat Chem Biol. 2006 Sep;2(9):486-93. doi: 10.1038/nchembio813. Epub 2006 Aug 13.
PubMed 16906150Tang WH, Wang Z, Cho L, Brennan DM, Hazen SL. Diminished global arginine bioavailability and increased arginine catabolism as metabolic profile of increased cardiovascular risk. J Am Coll Cardiol. 2009 Jun 2;53(22):2061-7. doi: 10.1016/j.jacc.2009.02.036.
PubMed 19477356Mullens W, Abrahams Z, Francis GS, Sokos G, Starling RC, Young JB, Taylor DO, Tang WH. Usefulness of Isosorbide Dinitrate and Hydralazine as add-on therapy in patients discharged for advanced decompensated heart failure. Am J Cardiol. 2009 Apr 15;103(8):1113-9. doi: 10.1016/j.amjcard.2008.12.028. Epub 2009 Feb 21.
PubMed 19361599Taylor AL, Ziesche S, Yancy C, Carson P, D'Agostino R Jr, Ferdinand K, Taylor M, Adams K, Sabolinski M, Worcel M, Cohn JN; African-American Heart Failure Trial Investigators. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004 Nov 11;351(20):2049-57. doi: 10.1056/NEJMoa042934. Epub 2004 Nov 8.
PubMed 15533851Hare JM, Colucci WS. Role of nitric oxide in the regulation of myocardial function. Prog Cardiovasc Dis. 1995 Sep-Oct;38(2):155-66. doi: 10.1016/s0033-0620(05)80004-0.
PubMed 7568904Elahi MM, Naseem KM, Matata BM. Nitric oxide in blood. The nitrosative-oxidative disequilibrium hypothesis on the pathogenesis of cardiovascular disease. FEBS J. 2007 Feb;274(4):906-23. doi: 10.1111/j.1742-4658.2007.05660.x. Epub 2007 Jan 22.
PubMed 17244198Champion HC, Skaf MW, Hare JM. Role of nitric oxide in the pathophysiology of heart failure. Heart Fail Rev. 2003 Jan;8(1):35-46. doi: 10.1023/a:1022142904202.
PubMed 12652158Recchia FA. Role of nitric oxide in the regulation of substrate metabolism in heart failure. Heart Fail Rev. 2002 Apr;7(2):141-8. doi: 10.1023/a:1015324508556.
PubMed 11988638Mullens W, Abrahams Z, Francis GS, Skouri HN, Starling RC, Young JB, Taylor DO, Tang WH. Sodium nitroprusside for advanced low-output heart failure. J Am Coll Cardiol. 2008 Jul 15;52(3):200-7. doi: 10.1016/j.jacc.2008.02.083.
PubMed 18617068Carson P, Ziesche S, Johnson G, Cohn JN. Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. Vasodilator-Heart Failure Trial Study Group. J Card Fail. 1999 Sep;5(3):178-87. doi: 10.1016/s1071-9164(99)90001-5.
PubMed 10496190Vanderheyden M, Bartunek J, Knaapen M, Kockx M, De Bruyne B, Goethals M. Hemodynamic effects of inducible nitric oxide synthase and nitrotyrosine generation in heart failure. J Heart Lung Transplant. 2004 Jun;23(6):723-8. doi: 10.1016/j.healun.2003.07.015.
PubMed 15366433Pacher P, Schulz R, Liaudet L, Szabo C. Nitrosative stress and pharmacological modulation of heart failure. Trends Pharmacol Sci. 2005 Jun;26(6):302-10. doi: 10.1016/j.tips.2005.04.003.
PubMed 15925705Reinartz M, Ding Z, Flogel U, Godecke A, Schrader J. Nitrosative stress leads to protein glutathiolation, increased s-nitrosation, and up-regulation of peroxiredoxins in the heart. J Biol Chem. 2008 Jun 20;283(25):17440-9. doi: 10.1074/jbc.M800126200. Epub 2008 Apr 21.
PubMed 18426799Ungvari Z, Gupte SA, Recchia FA, Batkai S, Pacher P. Role of oxidative-nitrosative stress and downstream pathways in various forms of cardiomyopathy and heart failure. Curr Vasc Pharmacol. 2005 Jul;3(3):221-9. doi: 10.2174/1570161054368607.
PubMed 16026319
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitrative Stress in Heart Failure: The Cleveland Heart and Metabolic Prevention Study (CHAMPS)
- ClinicalTrials.gov ID
- NCT03012022
- Acronym / sponsor ID
- CHAMPS / 10-727
- Keywords
- Healthy Volunteers, Congestive Heart Failure, Cardiomyopathies, Heart Failure, Risk Factors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,208 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Nov 2010 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Jan 2017 (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.
The purpose of this research study is to investigate the role of chemical reactions, such as inflammation and oxidation, in the cause of cardiac dysfunction (the heart does not function properly). The investigators are interested in studying the various chemical pathways for cell damage to determine which are the most prevalent and/or most important. The investigators also want to determine whether waste products of oxidative damage or other chemicals can be monitored in the blood or urine and serve as an indication of the existence and severity of overall heart disease activity. The investigators further want to determine whether certain proteins, called enzymes, affect this cell damage, or whether the presence or absence of certain genes which create different forms of these enzymes correlate with the development of heart failure or cardiomyopathy (weakening of the heart muscle or a change in heart muscle structure) or other cardiovascular diseases.
Detailed description
This is a single-center study conducted at the Cleveland Clinic. The target population for this study is very broad and goes beyond any specific cohort or community. Participants will be mainly recruited from the greater Cleveland/Akron area, but any volunteer meeting the inclusion/exclusion criteria is eligible for participation.
The overall goal of the Cleveland Heart And Metabolic Prevention Study (CHAMPS) is to determine the role of nitrative stress in the development and progression of heart failure (HF) and left ventricular systolic dysfunction (LVSD). The investigators have previously developed and performed preliminary clinical validation studies on multiple specific molecular footprints of known pathways of nitric oxide (NO) pathobiology that affect substrate availability for NO production or generation of NO-derived oxidants as a result of nitrative stress. For each these molecular markers and indices, mechanistic links to cardiovascular diseases have been demonstrated. However, these processes may be differentially expressed in different proportions at different stages of LVSD/HF disease progression, and certainly may vary among different individuals. It is the investigators' hypothesis that the interplay of many of these processes contribute to development of subclinical myocardial dysfunction (SMD), and the progression to overt LVSD and HF.
In order to help determine the role of nitrative stress in the development and progression of heart failure and left ventricular systolic dysfunction study participants will receive many non-invasive, research only, procedures as well as a blood draw and urine collection. The procedures performed may include electrocardiogram (ECG), echocardiogram, carotid intima-medial thickness measurements, ankle-brachial index, bioelectrical impedance analysis, pulse wave velocity analysis, spirometry, exhaled nitric oxide analysis, and venous occlusion strain-gauge plethysmography. The specific tests performed on each participant will be at the description of the primary investigator and not all participants will receive all tests. All participants will have blood and urine collections and all participants will be asked to fill out questionnaires pertaining to family history, personal medical history and estimates of functional capacity.
Specific aims include:
Aim 1: To test the hypothesis that levels of specific nitric oxide (NO)-mediated processes are associated with the presence of SMD and LVSD/HF.
Aim 2: To test the hypothesis that levels of specific NO-mediated processes are associated with prospective risks for development of adverse cardiovascular events and overt HF in stable patients without LVSD/HF at baseline.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Volunteers without known cardiomyopathy or heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (2 listed)
- Either age 40 years or older OR age 18 years or older with a family history of heart failure or cardiac dysfunction (the heart does not function properly).
- Able and willing to consent to the study protocol, including an overnight (≥10 hour) fast.
Key exclusion criteria (4 listed)
- Known history of heart failure or cardiomyopathy (LVSD, defined by left ventricular ejection fraction ≤45%) at the time of enrollment
- Major cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism), or major surgery <1 month of enrollment of present study (subject can be considered enrollment after 1 month if deemed clinically stable)
- Any hospitalization or emergency room visits for any cause <1 month of enrollment present study
- Known life expectancy <6 months at the time of enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between metabolic and/or nitrative stress markers and predefined clinical endpoints
Time frame: 10 years
Clinical endpoints include acute myocardial infarction, acute coronary syndrome, congestive heart failure, serious cardiac arrhythmia, peripheral vascular disease, cerebrovascular events and death. Events will be aggregated into a common category (e.g. MACE) for statistical analysis and reporting. These aggregated events data will then be correlated with each biomarker of interest.
5 secondary outcomes
Determination of sub-clinical myocardial dysfunction by echocardiogram
Time frame: 10 years
Correlation between DASI functional capacity and markers of metabolic and nitrative stress
Time frame: 10 years
Correlation between SF36 functional capacity and markers of metabolic and nitrative stress
Time frame: 10 years
Correlation between DASI functional capacity and markers of cardiac dysfunction
Time frame: 10 years
Correlation between SF36 functional capacity and markers of cardiac dysfunction
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Background: PubMed 11090610Abu-Soud HM, Hazen SL. Nitric oxide is a physiological substrate for mammalian peroxidases. J Biol Chem. 2000 Dec 1;275(48):37524-32. doi: 10.1074/jbc.275.48.37524.
- Background: PubMed 16906150Shiva S, Wang X, Ringwood LA, Xu X, Yuditskaya S, Annavajjhala V, Miyajima H, Hogg N, Harris ZL, Gladwin MT. Ceruloplasmin is a NO oxidase and nitrite synthase that determines endocrine NO homeostasis. Nat Chem Biol. 2006 Sep;2(9):486-93. doi: 10.1038/nchembio813. Epub 2006 Aug 13.
- Background: PubMed 19477356Tang WH, Wang Z, Cho L, Brennan DM, Hazen SL. Diminished global arginine bioavailability and increased arginine catabolism as metabolic profile of increased cardiovascular risk. J Am Coll Cardiol. 2009 Jun 2;53(22):2061-7. doi: 10.1016/j.jacc.2009.02.036.
- Background: PubMed 19361599Mullens W, Abrahams Z, Francis GS, Sokos G, Starling RC, Young JB, Taylor DO, Tang WH. Usefulness of Isosorbide Dinitrate and Hydralazine as add-on therapy in patients discharged for advanced decompensated heart failure. Am J Cardiol. 2009 Apr 15;103(8):1113-9. doi: 10.1016/j.amjcard.2008.12.028. Epub 2009 Feb 21.
- Background: PubMed 15533851Taylor AL, Ziesche S, Yancy C, Carson P, D'Agostino R Jr, Ferdinand K, Taylor M, Adams K, Sabolinski M, Worcel M, Cohn JN; African-American Heart Failure Trial Investigators. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004 Nov 11;351(20):2049-57. doi: 10.1056/NEJMoa042934. Epub 2004 Nov 8.
- Background: PubMed 7568904Hare JM, Colucci WS. Role of nitric oxide in the regulation of myocardial function. Prog Cardiovasc Dis. 1995 Sep-Oct;38(2):155-66. doi: 10.1016/s0033-0620(05)80004-0.
- Background: PubMed 17244198Elahi MM, Naseem KM, Matata BM. Nitric oxide in blood. The nitrosative-oxidative disequilibrium hypothesis on the pathogenesis of cardiovascular disease. FEBS J. 2007 Feb;274(4):906-23. doi: 10.1111/j.1742-4658.2007.05660.x. Epub 2007 Jan 22.
- Background: PubMed 12652158Champion HC, Skaf MW, Hare JM. Role of nitric oxide in the pathophysiology of heart failure. Heart Fail Rev. 2003 Jan;8(1):35-46. doi: 10.1023/a:1022142904202.
- Background: PubMed 11988638Recchia FA. Role of nitric oxide in the regulation of substrate metabolism in heart failure. Heart Fail Rev. 2002 Apr;7(2):141-8. doi: 10.1023/a:1015324508556.
- Background: PubMed 18617068Mullens W, Abrahams Z, Francis GS, Skouri HN, Starling RC, Young JB, Taylor DO, Tang WH. Sodium nitroprusside for advanced low-output heart failure. J Am Coll Cardiol. 2008 Jul 15;52(3):200-7. doi: 10.1016/j.jacc.2008.02.083.
- Background: PubMed 10496190Carson P, Ziesche S, Johnson G, Cohn JN. Racial differences in response to therapy for heart failure: analysis of the vasodilator-heart failure trials. Vasodilator-Heart Failure Trial Study Group. J Card Fail. 1999 Sep;5(3):178-87. doi: 10.1016/s1071-9164(99)90001-5.
- Background: PubMed 15366433Vanderheyden M, Bartunek J, Knaapen M, Kockx M, De Bruyne B, Goethals M. Hemodynamic effects of inducible nitric oxide synthase and nitrotyrosine generation in heart failure. J Heart Lung Transplant. 2004 Jun;23(6):723-8. doi: 10.1016/j.healun.2003.07.015.
- Individual participant dataSharing planned: No
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.
W. H. Wilson Tang, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure Risk Factors in Healthy Individuals, run by The Cleveland Clinic 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between metabolic and/or nitrative stress markers and predefined clinical endpoints (time frame: 10 years). 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 NCT03012022, which also lists 28 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 25 Jun 2026.