Cardiogenic ShockPhase 2HEROICNCT00445211
HEROIC (Heparin Requirement in Counterpulsation)
A Phase 2 study testing Heparin and Without Heparin in people with Cardiogenic Shock, run by Corewell Health East at 1 site in United States.
Trial summary
Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the work of the heart and improving blood flow to the coronary arteries) often receive intravenous (IV) heparin (a "blood thinner") to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Heparin and Without Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Mar 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- Able to provide consent
- Insertion of Intra-aortic Balloon Pump (IABP) in William Beaumont Hospital (WBH) cath lab
- Anticipated duration of IABP >/= 18 hours
Who cannot join
- Contraindications to heparin
- Pre-existing condition requiring heparin administration (other than IABP)
- IABP placed outside of the WBH cardiac catheterization lab prophylactically for high-risk percutaneous coronary intervention (PCI), without complications)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Heparin Requirement in Counterpulsation
Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the work of the heart and improving blood flow to the coronary arteries) often receive intravenous (IV) heparin (a "blood thinner") to prevent circulation problems in the leg (where they are inserted). When intra-aortic balloon pumps were initially developed, the catheters were larger than the catheters used today. Due to the large size of the catheter and the material used to make the catheter, it was thought that intravenous heparin would prevent poor blood flow to the leg that contained the temporary catheter. Intravenous heparin, however, has never been proven to maintain good blood flow in these patients. The catheters used with intra-aortic balloon pumps are now smaller in size and made of a material that is less likely to produce blood clots. It is not clear that heparin is needed with intra-aortic balloon pumps. Bleeding complications associated with intra-aortic balloon pumps may be decreased if heparin is not used. In 2004, 99 patients received intra-aortic balloon pumps in the cardiac catheterization labs at William Beaumont Hospital. These patients received intravenous heparin and experienced a large number of bleeding complications (27 patients required a blood transfusion). This study will help the investigators to clarify if heparin should or should not be routinely used in patients with intra-aortic balloon pumps.
Read the detailed description
Potential patients will be identified in the cardiac catheterization lab when an intra-aortic balloon pump is placed. Patients who agree to participate in this study will be randomized (they will be selected to receive heparin or not to receive heparin with their intra-aortic balloon pump) by a process that is similar to flipping a coin. Patients will have a 50% chance of receiving heparin and a 50% chance of not receiving heparin. If a patient does not want to participate in the study, his/her cardiologist will decide if the patient will receive or not receive heparin. Intra-aortic balloon pumps have been used with and without intravenous heparin and there is no known increase in complications in patients who do not receive heparin. Risks include bleeding and possible blood clots/decreased blood flow to the leg with the catheter in both groups (due to different medical reasons). The patients in both groups will be monitored closely in the cardiac care unit while the intra-aortic balloon pump is in place to prevent and/or minimize complications.
- Conditions
- Cardiogenic Shock
- Being tested
- Heparin, Without Heparin
- Keywords
- Intraaortic balloon pumping, Heparin, Limb ischemia, Bleeding
- Medical subject headings
- Shock, Cardiogenic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
Heparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP).
Without HeparinOther
Intra-Aortic balloon Pump (IABP) without Heparin.
| Study group | Role | What they receive |
|---|---|---|
| Intra-Aortic balloon Pump with Heparin | Active comparator | Intra-Aortic Balloon Pump (IABP) with Heparin Receives: Drug: Heparin |
| Intra-Aortic balloon Pump without Heparin | Active comparator | Intra-Aortic balloon Pump (IABP) without Heparin Receives: Other: Without Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization
Count of participants with decreased arterial flow in lower extremity as presented by diminished pulse that resolves with balloon removal, and not resulting in any impairment of body function
Measured: 0-4 days post surgery
Major Ischemia (Decreased Blood Flow) During the Index Hospitalization
Count of participants with loss of Doppler signal or sensation or abnormal skin temperature, mottling or pallor in lower extremity requiring surgical intervention; or other major ischemic events including ischemic stroke; recurrent unstable ischemia (unstable angina, recurrent chest pain prompting definitive treatment such as re-percutaneous transluminal coronary angiography (PTCA), coronary artery bypass grafting (CABG), administration of thrombolytics); reinfarction including clinical symptoms or new ECG changes with creatine kinase (CK) elevation and positive creatine kinase-MB isoenzyme fraction; arterial thrombosis, embolus, dissection, or perforation; compartment syndrome; renal ischemia including new renal failure or need for dialysis; small bowel or splenic infarction; mesenteric or hepatic ischemia, or deep vein thrombosis.
Measured: 0-4 days post surgery
Major Bleeding During the Index Hospitalization
Count of participants with hemorrhage associated with at least one of the following features as defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria: Bleeding that results in a decrease in hemoglobin >/= 5g.dL or a hematocrit decrease of >/= 15% of baseline value; bleeding that is intracranial (confirmed by MRI or CT); bleeding that results in death.
Measured: 0-4 days post surgery
Secondary outcomes (2)
Intra-aortic Balloon Pump-related Death During the Index Hospitalization
Measured: 0-4 days post surgery
Hospital Death During the Index Hospitalization
Measured: 0-4 post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startJan 2006
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Trivax, Corewell Health East
- Investigators
- Justin Trivax, M.D., Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445211
- Sponsor's protocol ID
- 2006-001
- Acronym
- HEROIC
- Status last verified
- Apr 2017
- First submitted
- 6 Mar 2007
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baim DS, Grossman W. Grossman's Cardiac Catheterization, Angiography and Intervention (6th Ed). Lippincott Williams & Williams, Philadelphia, Pennsylvania, 2000, 463.
MOULOPOULOS SD, TOPAZ S, KOLFF WJ. Diastolic balloon pumping (with carbon dioxide) in the aorta--a mechanical assistance to the failing circulation. Am Heart J. 1962 May;63:669-75. doi: 10.1016/0002-8703(62)90012-1. No abstract available.
PubMed 14476645Kantrowitz A. Origins of intraaortic balloon pumping. Ann Thorac Surg. 1990 Oct;50(4):672-4. doi: 10.1016/0003-4975(90)90220-z.
PubMed 2222066Stone GW, Ohman EM, Miller MF, Joseph DL, Christenson JT, Cohen M, Urban PM, Reddy RC, Freedman RJ, Staman KL, Ferguson JJ 3rd. Contemporary utilization and outcomes of intra-aortic balloon counterpulsation in acute myocardial infarction: the benchmark registry. J Am Coll Cardiol. 2003 Jun 4;41(11):1940-5. doi: 10.1016/s0735-1097(03)00400-5.
PubMed 12798561Cohen M, Dawson MS, Kopistansky C, McBride R. Sex and other predictors of intra-aortic balloon counterpulsation-related complications: prospective study of 1119 consecutive patients. Am Heart J. 2000 Feb;139(2 Pt 1):282-7. doi: 10.1067/mhj.2000.101489.
PubMed 10650301Alle KM, White GH, Harris JP, May J, Baird D. Iatrogenic vascular trauma associated with intra-aortic balloon pumping: identification of risk factors. Am Surg. 1993 Dec;59(12):813-7.
PubMed 8256934Walls JT, Boley TM, Curtis JJ, Silver D. Heparin induced thrombocytopenia in patients undergoing intra-aortic balloon pumping after open heart surgery. ASAIO J. 1992 Jul-Sep;38(3):M574-6. doi: 10.1097/00002480-199207000-00100.
PubMed 1457924Ficek SJ, Stammers A, Deligonul U, Shurmur SW, Alonso A, Galbraith T. Hemostatic assessment of patients undergoing intraaortic balloon pump therapy. J Extra Corpor Technol. 1997 Jun;29(2):78-82.
PubMed 10168534Busch T, Sirbu H, Zenker D, Dalichau H. Vascular complications related to intraaortic balloon counterpulsation: an analysis of ten years experience. Thorac Cardiovasc Surg. 1997 Apr;45(2):55-9. doi: 10.1055/s-2007-1013687.
PubMed 9175219Todd GJ, Bregman D, Voorhees AB, Reemtsma K. Vascular complications associated with percutaneous intra-aortic balloon pumping. Arch Surg. 1983 Aug;118(8):963-4. doi: 10.1001/archsurg.1983.01390080065016.
PubMed 6870526Jiang CY, Zhao LL, Wang JA, Mohammod B. Anticoagulation therapy in intra-aortic balloon counterpulsation: does IABP really need anti-coagulation? J Zhejiang Univ Sci. 2003 Sep-Oct;4(5):607-11. doi: 10.1631/jzus.2003.0607.
PubMed 12958723Sato K, Tokairin H, Kato M. [Two patients treated with intra-aortic balloon pump counterpulsation after subarachnoid hemorrhage]. Masui. 2001 Aug;50(8):859-62. Japanese.
PubMed 11554017Vonderheide RH, Thadhani R, Kuter DJ. Association of thrombocytopenia with the use of intra-aortic balloon pumps. Am J Med. 1998 Jul;105(1):27-32. doi: 10.1016/s0002-9343(98)00128-4.
PubMed 9688018Schreiber TL, Kodali UR, O'Neill WW, Gangadharan V, Puchrowicz-Ochocki SB, Grines CL. Comparison of acute results of prophylactic intraaortic balloon pumping with cardiopulmonary support for percutaneous transluminal coronary angioplasty (PCTA). Cathet Cardiovasc Diagn. 1998 Oct;45(2):115-9. doi: 10.1002/(sici)1097-0304(199810)45:23.0.co;2-f.
PubMed 9786386
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Requirement in Counterpulsation
- ClinicalTrials.gov ID
- NCT00445211
- Acronym / sponsor ID
- HEROIC / 2006-001
- Conditions
- Cardiogenic Shock
- Keywords
- Intraaortic balloon pumping, Heparin, Limb ischemia, Bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of enrollment
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Posted 19 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with intra-aortic balloon pumps (catheters placed in the groin connected to a pump which assists the heart by opening and closing a balloon in the aorta, thereby decreasing the work of the heart and improving blood flow to the coronary arteries) often receive intravenous (IV) heparin (a "blood thinner") to prevent circulation problems in the leg (where they are inserted). When intra-aortic balloon pumps were initially developed, the catheters were larger than the catheters used today. Due to the large size of the catheter and the material used to make the catheter, it was thought that intravenous heparin would prevent poor blood flow to the leg that contained the temporary catheter. Intravenous heparin, however, has never been proven to maintain good blood flow in these patients. The catheters used with intra-aortic balloon pumps are now smaller in size and made of a material that is less likely to produce blood clots. It is not clear that heparin is needed with intra-aortic balloon pumps. Bleeding complications associated with intra-aortic balloon pumps may be decreased if heparin is not used. In 2004, 99 patients received intra-aortic balloon pumps in the cardiac catheterization labs at William Beaumont Hospital. These patients received intravenous heparin and experienced a large number of bleeding complications (27 patients required a blood transfusion). This study will help the investigators to clarify if heparin should or should not be routinely used in patients with intra-aortic balloon pumps.
Detailed description
Potential patients will be identified in the cardiac catheterization lab when an intra-aortic balloon pump is placed. Patients who agree to participate in this study will be randomized (they will be selected to receive heparin or not to receive heparin with their intra-aortic balloon pump) by a process that is similar to flipping a coin. Patients will have a 50% chance of receiving heparin and a 50% chance of not receiving heparin. If a patient does not want to participate in the study, his/her cardiologist will decide if the patient will receive or not receive heparin. Intra-aortic balloon pumps have been used with and without intravenous heparin and there is no known increase in complications in patients who do not receive heparin. Risks include bleeding and possible blood clots/decreased blood flow to the leg with the catheter in both groups (due to different medical reasons). The patients in both groups will be monitored closely in the cardiac care unit while the intra-aortic balloon pump is in place to prevent and/or minimize complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-Aortic balloon Pump with Heparin | Active comparator | Drug: HeparinIntra-Aortic Balloon Pump (IABP) with Heparin |
| Intra-Aortic balloon Pump without Heparin | Active comparator | Other: Without HeparinIntra-Aortic balloon Pump (IABP) without Heparin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >/= 18 years
- Able to provide consent
- Insertion of Intra-aortic Balloon Pump (IABP) in William Beaumont Hospital (WBH) cath lab
- Anticipated duration of IABP >/= 18 hours
Key exclusion criteria (4 listed)
- Contraindications to heparin
- Pre-existing condition requiring heparin administration (other than IABP)
- IABP placed outside of the WBH cardiac catheterization lab prophylactically for high-risk percutaneous coronary intervention (PCI), without complications)
- Pregnant women
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 |
|---|---|---|
| HeparinHeparin administered at 500units/hour while on Intra-Aortic balloon Pump (IABP). | Drug | Intra-Aortic balloon Pump with Heparin |
| Without HeparinIntra-Aortic balloon Pump (IABP) without Heparin. | Other | Intra-Aortic balloon Pump without Heparin |
Primary outcome
Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization
Time frame: 0-4 days post surgery
Count of participants with decreased arterial flow in lower extremity as presented by diminished pulse that resolves with balloon removal, and not resulting in any impairment of body function
Major Ischemia (Decreased Blood Flow) During the Index Hospitalization
Time frame: 0-4 days post surgery
Count of participants with loss of Doppler signal or sensation or abnormal skin temperature, mottling or pallor in lower extremity requiring surgical intervention; or other major ischemic events including ischemic stroke; recurrent unstable ischemia (unstable angina, recurrent chest pain prompting definitive treatment such as re-percutaneous transluminal coronary angiography (PTCA), coronary artery bypass grafting (CABG), administration of thrombolytics); reinfarction including clinical symptoms or new ECG changes with creatine kinase (CK) elevation and positive creatine kinase-MB isoenzyme fraction; arterial thrombosis, embolus, dissection, or perforation; compartment syndrome; renal ischemia including new renal failure or need for dialysis; small bowel or splenic infarction; mesenteric or hepatic ischemia, or deep vein thrombosis.
Major Bleeding During the Index Hospitalization
Time frame: 0-4 days post surgery
Count of participants with hemorrhage associated with at least one of the following features as defined by the Thrombolysis in Myocardial Infarction (TIMI) Study Group criteria: Bleeding that results in a decrease in hemoglobin >/= 5g.dL or a hematocrit decrease of >/= 15% of baseline value; bleeding that is intracranial (confirmed by MRI or CT); bleeding that results in death.
2 secondary outcomes
Intra-aortic Balloon Pump-related Death During the Index Hospitalization
Time frame: 0-4 days post surgery
Hospital Death During the Index Hospitalization
Time frame: 0-4 post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundBaim DS, Grossman W. Grossman's Cardiac Catheterization, Angiography and Intervention (6th Ed). Lippincott Williams & Williams, Philadelphia, Pennsylvania, 2000, 463.
- Background: PubMed 14476645MOULOPOULOS SD, TOPAZ S, KOLFF WJ. Diastolic balloon pumping (with carbon dioxide) in the aorta--a mechanical assistance to the failing circulation. Am Heart J. 1962 May;63:669-75. doi: 10.1016/0002-8703(62)90012-1. No abstract available.
- Background: PubMed 2222066Kantrowitz A. Origins of intraaortic balloon pumping. Ann Thorac Surg. 1990 Oct;50(4):672-4. doi: 10.1016/0003-4975(90)90220-z.
- Background: PubMed 12798561Stone GW, Ohman EM, Miller MF, Joseph DL, Christenson JT, Cohen M, Urban PM, Reddy RC, Freedman RJ, Staman KL, Ferguson JJ 3rd. Contemporary utilization and outcomes of intra-aortic balloon counterpulsation in acute myocardial infarction: the benchmark registry. J Am Coll Cardiol. 2003 Jun 4;41(11):1940-5. doi: 10.1016/s0735-1097(03)00400-5.
- Background: PubMed 10650301Cohen M, Dawson MS, Kopistansky C, McBride R. Sex and other predictors of intra-aortic balloon counterpulsation-related complications: prospective study of 1119 consecutive patients. Am Heart J. 2000 Feb;139(2 Pt 1):282-7. doi: 10.1067/mhj.2000.101489.
- Background: PubMed 8256934Alle KM, White GH, Harris JP, May J, Baird D. Iatrogenic vascular trauma associated with intra-aortic balloon pumping: identification of risk factors. Am Surg. 1993 Dec;59(12):813-7.
- Background: PubMed 1457924Walls JT, Boley TM, Curtis JJ, Silver D. Heparin induced thrombocytopenia in patients undergoing intra-aortic balloon pumping after open heart surgery. ASAIO J. 1992 Jul-Sep;38(3):M574-6. doi: 10.1097/00002480-199207000-00100.
- Background: PubMed 10168534Ficek SJ, Stammers A, Deligonul U, Shurmur SW, Alonso A, Galbraith T. Hemostatic assessment of patients undergoing intraaortic balloon pump therapy. J Extra Corpor Technol. 1997 Jun;29(2):78-82.
- Background: PubMed 9175219Busch T, Sirbu H, Zenker D, Dalichau H. Vascular complications related to intraaortic balloon counterpulsation: an analysis of ten years experience. Thorac Cardiovasc Surg. 1997 Apr;45(2):55-9. doi: 10.1055/s-2007-1013687.
- Background: PubMed 6870526Todd GJ, Bregman D, Voorhees AB, Reemtsma K. Vascular complications associated with percutaneous intra-aortic balloon pumping. Arch Surg. 1983 Aug;118(8):963-4. doi: 10.1001/archsurg.1983.01390080065016.
- Background: PubMed 12958723Jiang CY, Zhao LL, Wang JA, Mohammod B. Anticoagulation therapy in intra-aortic balloon counterpulsation: does IABP really need anti-coagulation? J Zhejiang Univ Sci. 2003 Sep-Oct;4(5):607-11. doi: 10.1631/jzus.2003.0607.
- Background: PubMed 11554017Sato K, Tokairin H, Kato M. [Two patients treated with intra-aortic balloon pump counterpulsation after subarachnoid hemorrhage]. Masui. 2001 Aug;50(8):859-62. Japanese.
- Individual participant dataSharing planned: No
Related trials for Cardiogenic Shock
Not yet recruitingPhase 4
Capital Offload-Shock
Hypervolemia, Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
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.
Justin Trivax, M.D. principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Heparin and Without Heparin in people with Cardiogenic Shock, run by Corewell Health East 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 4 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: stopped early, as of the sponsor's last update on 19 May 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minor Ischemia (Decreased Blood Flow) During the Index Hospitalization (time frame: 0-4 days post surgery). The study lists 3 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 NCT00445211, which also lists 14 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 19 May 2017.