Tuberculous PericarditisPhase 3IMPINCT00810849
A Trial of Adjunctive Prednisolone and Mycobacterium w Immunotherapy in Tuberculous Pericarditis
A Phase 3 study testing Prednisolone and Mycobacterium w immunotherapy in people with Tuberculous Pericarditis, run by University of Cape Town at 1 site in South Africa.
Trial summary
Human immunodeficiency virus (HIV) infection puts people at risk of opportunistic infections, such as tuberculosis. In Africa, the HIV epidemic has resulted in an increase in the number of cases of tuberculosis affecting various parts of the body, including the membrane surrounding the heart (i.e., pericardium). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculous Pericarditis
- What is being tested?
- Prednisolone and Mycobacterium w immunotherapy
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,400 participants
- Where
- 1 siteSouth Africa
- Study dates
- Dec 2008to Aug 2014
- 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
- Patients admitted with suspected tuberculous pericarditis will be eligible if they meet all three of the following criteria:
- A confirmed pericardial effusion on echocardiography;
- Evidence of definite or probable tuberculous pericarditis; and
- Within 1 week of starting of antituberculosis treatment.
Who cannot join
- Presence of an alternative cause of pericardial disease, e.g., penetrating chest trauma in the previous 12 months and malignancy.
- Use of corticosteroids within the previous month.
- Hypersensitivity or allergy to the Mycobacterium w vaccine.
- Pregnancy.
- Age < 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Human immunodeficiency virus (HIV) infection puts people at risk of opportunistic infections, such as tuberculosis. In Africa, the HIV epidemic has resulted in an increase in the number of cases of tuberculosis affecting various parts of the body, including the membrane surrounding the heart (i.e., pericardium). Pericardial tuberculosis is a serious form of tuberculosis that results in the death or disability of 1 in 2 affected people despite the use of antituberculosis medication. It has been suggested that the addition of corticosteroids to the antituberculosis medication could result in the reduction of the number of deaths caused by the disease, but this proposal remains to be confirmed in appropriately designed clinical trials. Similarly, vaccination with the Mycobacterium w injection is also proposed as a possible way of reducing the damage caused by the tuberculosis infection of the heart. The investigators are proposing to conduct a clinical trial in which people who are on antituberculosis treatment for pericardial tuberculosis will be randomly allocated to receive either prednisolone or a matching placebo tablet, or Mycobacterium w injection or placebo injection. The number of people who die or who develop hardening of the pericardium with compression of the heart (called pericardial constriction) or who need emergency evacuation of the pericardial fluid from pericardial sac for severe compression (called tamponade) will be compared in each group to determine whether the use of corticosteroids or Mycobacterium w injection is safe and results in reduction in the death rate. If corticosteroids and Mycobacterium w are shown to safely reduce the death rate, then they will be recommended for use in all patients with tuberculosis of the pericardium in the future.
Read the detailed description
Summary of research proposal Tuberculous pericarditis is one of the most severe forms of infection with Mycobacterium tuberculosis, causing death or cardiac disability in nearly half of those affected in spite of antituberculosis chemotherapy. Attenuation of the inflammatory response in tuberculous pericarditis may improve outcome by reducing the likelihood of cardiac tamponade and pericardial constriction. A meta-analysis of all randomized controlled trials of corticosteroids for tuberculous pericarditis showed a trend towards reduction of mortality, but the studies were too small to confirm any effect on survival. Concern remains that corticosteroids might increase the frequency of opportunistic infections and cancers in patients infected with the Human Immunodeficiency Virus (HIV). In addition to the promising but inconclusive evidence on adjunctive steroids, there is preliminary evidence suggesting that repeated doses of Mycobacterium w immunotherapy may reduce the inflammation associated with extrapulmonary tuberculosis and increase the CD4 cell count in people infected with HIV. These early observations remain to be tested in a large randomized trial with the hard endpoint of mortality.
The Investigation of the Management of Pericarditis in Africa (IMPI [pronounced as 'ee-mp-ee', for Zulu warriors]) Trial will assess effectiveness and safety of oral prednisolone or placebo and Mycobacterium w immunotherapy or placebo in 1400 patients with tuberculous pericardial effusion. This trial will also determine the feasibility of conducting a large-scale multicentre clinical trial in patients with tuberculous pericarditis in sub-Saharan Africa.
Hypothesis: We hypothesize that patients with suspected tuberculous pericarditis randomized to adjunctive oral prednisolone for 6 weeks will have a 30% reduction in mortality compared to placebo, and that patients randomized to Mycobacterium w injections for 6 months will have a better survival compared to placebo.
Objectives: The primary objectives of the IMPI Trial are: a) to determine the effectiveness of oral prednisolone and Mycobacterium w immunotherapy in reducing the composite outcome of death, constriction or pericardial drainage for cardiac tamponade in patients with tuberculous pericardial effusion, b) to assess the safety and interactive effects of the co-administration of prednisolone and Mycobacterium w immunotherapy, and c) to demonstrate the feasibility of conducting a study in patients with tuberculous pericardial effusion in sub-Saharan Africa, and establish the infrastructure for conducting the full-scale IMPI trial in an internal pilot phase of the first 200 participants.
If the internal pilot phase is positive, all the patients will be rolled-over into the full-scale IMPI trial. The first occurrence of death will be recorded to improve estimates of outcomes for the full-scale trial. Secondary outcomes of the full-scale trial will include: 1) constriction, 2) rate of occurrence of cardiac tamponade requiring pericardiocentesis, 3) rate of resolution of pericardial effusion, 4) improvement in functional class.
Study Design: IMPI is a randomized double-blind placebo-controlled 2x2 factorial pilot trial that will enroll 1400 patients from multiple centres in Kenya, Malawi, Mozambique, Nigeria, Sierra Leone, South Africa, Uganda and Zimbabwe. Patients with tuberculous pericarditis who fulfill the inclusion criteria will be randomly assigned to receive oral prednisolone or placebo for 6 weeks and Mycobacterium w injection or placebo for 6 months. Patients will be followed closely during the intervention period (at weeks 2, 4, 6, and months 3 and 6). Six-monthly follow-up will be performed thereafter for up to two years. The recruitment of the 1400 patients will be performed over 54 months, with a minimum follow-up period of 6 months for the last participants recruited in the trial. The Population Health Research Institute at McMaster University will manage and coordinate the study in association with the IMPI Project Office that is located in the Department of Medicine, Groote Schuur Hospital, Cape Town, South Africa.
- Conditions
- Tuberculous Pericarditis
- Being tested
- Prednisolone, Mycobacterium w immunotherapy
- Keywords
- Tuberculosis, pericardium
- Medical subject headings
- Pericarditis, Tuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called Medrol tablets
Prednisolone and placebo will be supplied as 5 mg identical tablets and given at a dosage of 120 mg/day in the first week, followed by 90 mg/day in the second week, 60 mg/day in the third week, 30 mg/day in the fourth week, 15 mg/day in the fifth week, and 5 mg/day in the sixth week.
Mycobacterium w immunotherapyBiological
Also called Immuvac
Patients enrolled in the Mycobacterium w experimental arm will receive 5 doses of 0.1 ml of the vaccine intradermally (on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months). Patients in the control arm of the Mycobacterium w comparison will receive a similar regime of placebo injections of normal saline in identically-packaged vials.
| Study group | Role | What they receive |
|---|---|---|
| Prednisolone | Placebo comparator | Six-week tapering course of prednisolone and those assigned to the prednisolone control arm will receive the same number of identically-coated placebo tablets. Receives: Drug: Prednisolone |
| Mycobacterium w | Placebo comparator | Patients enrolled in the Mycobacterium w experimental arm will receive 5 doses of 0.1 ml of the vaccine intradermally (on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months). Receives: Biological: Mycobacterium w immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite end-point of death, constriction, or cardiac tamponade requiring pericardial drainage.
Measured: Two years
Secondary outcomes (2)
Safety of immunomodulatory treatment
Measured: Two years
The secondary efficacy outcomes are the individual components of the composite primary outcome (i.e., death, constriction, and cardiac tamponade requiring pericardiocentesis), and all-cause hospitalization.
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 posted18 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionFeb 2014
- Study completionAug 2014
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 Tuberculous PericarditisStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Principal investigator, Bongani M Mayosi, University of Cape Town
- Investigators
- Salim Yusuf, M.D., Study chair, Population Health Research Institute, McMaster University, Hamilton, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810849
- Sponsor's protocol ID
- IMPI-TRIAL1
- Acronym
- IMPI
- Status last verified
- Sep 2014
- First submitted
- 17 Dec 2008
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mayosi BM, Ntsekhe M, Bosch J, Pogue J, Gumedze F, Badri M, Jung H, Pandie S, Smieja M, Thabane L, Francis V, Thomas KM, Thomas B, Awotedu AA, Magula NP, Naidoo DP, Damasceno A, Banda AC, Mutyaba A, Brown B, Ntuli P, Mntla P, Ntyintyane L, Ramjee R, Manga P, Kirenga B, Mondo C, Russell JB, Tsitsi JM, Peters F, Essop MR, Barasa AF, Mijinyawa MS, Sani MU, Olunuga T, Ogah O, Adebiyi A, Aje A, Ansa V, Ojji D, Danbauchi S, Hakim J, Matenga J, Yusuf S. Rationale and design of the Investigation of the Management of Pericarditis (IMPI) trial: a 2 x 2 factorial randomized double-blind multicenter trial of adjunctive prednisolone and Mycobacterium w immunotherapy in tuberculous pericarditis. Am Heart J. 2013 Feb;165(2):109-15.e3. doi: 10.1016/j.ahj.2012.08.006. Epub 2012 Dec 13.
PubMed 23351812Mayosi BM, Ntsekhe M, Bosch J, Pandie S, Jung H, Gumedze F, Pogue J, Thabane L, Smieja M, Francis V, Joldersma L, Thomas KM, Thomas B, Awotedu AA, Magula NP, Naidoo DP, Damasceno A, Chitsa Banda A, Brown B, Manga P, Kirenga B, Mondo C, Mntla P, Tsitsi JM, Peters F, Essop MR, Russell JB, Hakim J, Matenga J, Barasa AF, Sani MU, Olunuga T, Ogah O, Ansa V, Aje A, Danbauchi S, Ojji D, Yusuf S; IMPI Trial Investigators. Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis. N Engl J Med. 2014 Sep 18;371(12):1121-30. doi: 10.1056/NEJMoa1407380. Epub 2014 Sep 1.
PubMed 25178809
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Adjunctive Prednisolone and Mycobacterium w Immunotherapy in Tuberculous Pericarditis
- ClinicalTrials.gov ID
- NCT00810849
- Acronym / sponsor ID
- IMPI / IMPI-TRIAL1
- Conditions
- Tuberculous Pericarditis
- Keywords
- Tuberculosis, pericardium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- Dec 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Dec 2008 (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.
Human immunodeficiency virus (HIV) infection puts people at risk of opportunistic infections, such as tuberculosis. In Africa, the HIV epidemic has resulted in an increase in the number of cases of tuberculosis affecting various parts of the body, including the membrane surrounding the heart (i.e., pericardium). Pericardial tuberculosis is a serious form of tuberculosis that results in the death or disability of 1 in 2 affected people despite the use of antituberculosis medication. It has been suggested that the addition of corticosteroids to the antituberculosis medication could result in the reduction of the number of deaths caused by the disease, but this proposal remains to be confirmed in appropriately designed clinical trials. Similarly, vaccination with the Mycobacterium w injection is also proposed as a possible way of reducing the damage caused by the tuberculosis infection of the heart. The investigators are proposing to conduct a clinical trial in which people who are on antituberculosis treatment for pericardial tuberculosis will be randomly allocated to receive either prednisolone or a matching placebo tablet, or Mycobacterium w injection or placebo injection. The number of people who die or who develop hardening of the pericardium with compression of the heart (called pericardial constriction) or who need emergency evacuation of the pericardial fluid from pericardial sac for severe compression (called tamponade) will be compared in each group to determine whether the use of corticosteroids or Mycobacterium w injection is safe and results in reduction in the death rate. If corticosteroids and Mycobacterium w are shown to safely reduce the death rate, then they will be recommended for use in all patients with tuberculosis of the pericardium in the future.
Detailed description
Summary of research proposal Tuberculous pericarditis is one of the most severe forms of infection with Mycobacterium tuberculosis, causing death or cardiac disability in nearly half of those affected in spite of antituberculosis chemotherapy. Attenuation of the inflammatory response in tuberculous pericarditis may improve outcome by reducing the likelihood of cardiac tamponade and pericardial constriction. A meta-analysis of all randomized controlled trials of corticosteroids for tuberculous pericarditis showed a trend towards reduction of mortality, but the studies were too small to confirm any effect on survival. Concern remains that corticosteroids might increase the frequency of opportunistic infections and cancers in patients infected with the Human Immunodeficiency Virus (HIV). In addition to the promising but inconclusive evidence on adjunctive steroids, there is preliminary evidence suggesting that repeated doses of Mycobacterium w immunotherapy may reduce the inflammation associated with extrapulmonary tuberculosis and increase the CD4 cell count in people infected with HIV. These early observations remain to be tested in a large randomized trial with the hard endpoint of mortality.
The Investigation of the Management of Pericarditis in Africa (IMPI [pronounced as 'ee-mp-ee', for Zulu warriors]) Trial will assess effectiveness and safety of oral prednisolone or placebo and Mycobacterium w immunotherapy or placebo in 1400 patients with tuberculous pericardial effusion. This trial will also determine the feasibility of conducting a large-scale multicentre clinical trial in patients with tuberculous pericarditis in sub-Saharan Africa.
Hypothesis: We hypothesize that patients with suspected tuberculous pericarditis randomized to adjunctive oral prednisolone for 6 weeks will have a 30% reduction in mortality compared to placebo, and that patients randomized to Mycobacterium w injections for 6 months will have a better survival compared to placebo.
Objectives: The primary objectives of the IMPI Trial are: a) to determine the effectiveness of oral prednisolone and Mycobacterium w immunotherapy in reducing the composite outcome of death, constriction or pericardial drainage for cardiac tamponade in patients with tuberculous pericardial effusion, b) to assess the safety and interactive effects of the co-administration of prednisolone and Mycobacterium w immunotherapy, and c) to demonstrate the feasibility of conducting a study in patients with tuberculous pericardial effusion in sub-Saharan Africa, and establish the infrastructure for conducting the full-scale IMPI trial in an internal pilot phase of the first 200 participants.
If the internal pilot phase is positive, all the patients will be rolled-over into the full-scale IMPI trial. The first occurrence of death will be recorded to improve estimates of outcomes for the full-scale trial. Secondary outcomes of the full-scale trial will include: 1) constriction, 2) rate of occurrence of cardiac tamponade requiring pericardiocentesis, 3) rate of resolution of pericardial effusion, 4) improvement in functional class.
Study Design: IMPI is a randomized double-blind placebo-controlled 2x2 factorial pilot trial that will enroll 1400 patients from multiple centres in Kenya, Malawi, Mozambique, Nigeria, Sierra Leone, South Africa, Uganda and Zimbabwe. Patients with tuberculous pericarditis who fulfill the inclusion criteria will be randomly assigned to receive oral prednisolone or placebo for 6 weeks and Mycobacterium w injection or placebo for 6 months. Patients will be followed closely during the intervention period (at weeks 2, 4, 6, and months 3 and 6). Six-monthly follow-up will be performed thereafter for up to two years. The recruitment of the 1400 patients will be performed over 54 months, with a minimum follow-up period of 6 months for the last participants recruited in the trial. The Population Health Research Institute at McMaster University will manage and coordinate the study in association with the IMPI Project Office that is located in the Department of Medicine, Groote Schuur Hospital, Cape Town, South Africa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolone | Placebo comparator | Drug: PrednisoloneSix-week tapering course of prednisolone and those assigned to the prednisolone control arm will receive the same number of identically-coated placebo tablets. |
| Mycobacterium w | Placebo comparator | Biological: Mycobacterium w immunotherapyPatients enrolled in the Mycobacterium w experimental arm will receive 5 doses of 0.1 ml of the vaccine intradermally (on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients admitted with suspected tuberculous pericarditis will be eligible if they meet all three of the following criteria:
- A confirmed pericardial effusion on echocardiography;
- Evidence of definite or probable tuberculous pericarditis; and
- Within 1 week of starting of antituberculosis treatment.
Key exclusion criteria (5 listed)
- Presence of an alternative cause of pericardial disease, e.g., penetrating chest trauma in the previous 12 months and malignancy.
- Use of corticosteroids within the previous month.
- Hypersensitivity or allergy to the Mycobacterium w vaccine.
- Pregnancy.
- Age < 18 years.
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 |
|---|---|---|
| PrednisoloneAlso: Medrol tabletsPrednisolone and placebo will be supplied as 5 mg identical tablets and given at a dosage of 120 mg/day in the first week, followed by 90 mg/day in the second week, 60 mg/day in the third week, 30 mg/day in the fourth week, 15 mg/day in the fifth week, and 5 mg/day in the sixth week. | Drug | Prednisolone |
| Mycobacterium w immunotherapyAlso: ImmuvacPatients enrolled in the Mycobacterium w experimental arm will receive 5 doses of 0.1 ml of the vaccine intradermally (on enrolment, at 2 weeks, 4 weeks, 6 weeks, and 3 months). Patients in the control arm of the Mycobacterium w comparison will receive a similar regime of placebo injections of normal saline in identically-packaged vials. | Biological | Mycobacterium w |
Primary outcome
Composite end-point of death, constriction, or cardiac tamponade requiring pericardial drainage.
Time frame: Two years
2 secondary outcomes
Safety of immunomodulatory treatment
Time frame: Two years
The secondary efficacy outcomes are the individual components of the composite primary outcome (i.e., death, constriction, and cardiac tamponade requiring pericardiocentesis), and all-cause hospitalization.
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 3 Sep 2014.
- Background: PubMed 23351812Mayosi BM, Ntsekhe M, Bosch J, Pogue J, Gumedze F, Badri M, Jung H, Pandie S, Smieja M, Thabane L, Francis V, Thomas KM, Thomas B, Awotedu AA, Magula NP, Naidoo DP, Damasceno A, Banda AC, Mutyaba A, Brown B, Ntuli P, Mntla P, Ntyintyane L, Ramjee R, Manga P, Kirenga B, Mondo C, Russell JB, Tsitsi JM, Peters F, Essop MR, Barasa AF, Mijinyawa MS, Sani MU, Olunuga T, Ogah O, Adebiyi A, Aje A, Ansa V, Ojji D, Danbauchi S, Hakim J, Matenga J, Yusuf S. Rationale and design of the Investigation of the Management of Pericarditis (IMPI) trial: a 2 x 2 factorial randomized double-blind multicenter trial of adjunctive prednisolone and Mycobacterium w immunotherapy in tuberculous pericarditis. Am Heart J. 2013 Feb;165(2):109-15.e3. doi: 10.1016/j.ahj.2012.08.006. Epub 2012 Dec 13.
- Derived from this study: PubMed 25178809Mayosi BM, Ntsekhe M, Bosch J, Pandie S, Jung H, Gumedze F, Pogue J, Thabane L, Smieja M, Francis V, Joldersma L, Thomas KM, Thomas B, Awotedu AA, Magula NP, Naidoo DP, Damasceno A, Chitsa Banda A, Brown B, Manga P, Kirenga B, Mondo C, Mntla P, Tsitsi JM, Peters F, Essop MR, Russell JB, Hakim J, Matenga J, Barasa AF, Sani MU, Olunuga T, Ogah O, Ansa V, Aje A, Danbauchi S, Ojji D, Yusuf S; IMPI Trial Investigators. Prednisolone and Mycobacterium indicus pranii in tuberculous pericarditis. N Engl J Med. 2014 Sep 18;371(12):1121-30. doi: 10.1056/NEJMoa1407380. Epub 2014 Sep 1.
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.
Salim Yusuf, M.D. study chair
Population Health Research Institute, McMaster University, Hamilton, Canada
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 Prednisolone and Mycobacterium w immunotherapy in people with Tuberculous Pericarditis, 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 4 inclusion and 5 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 3 Sep 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
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?
Composite end-point of death, constriction, or cardiac tamponade requiring pericardial drainage. (time frame: Two 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 NCT00810849, 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 3 Sep 2014.