• Bongani M Mayosi, Mpiko Ntsekhe, Jackie Bosch, Janice Pogue, Freedom Gumedze, Motasim Badri, Hyejung Jung, Shaheen Pandie, Marek Smieja, Lehana Thabane, Veronica Francis, Kandithal M Thomas, Baby Thomas, Abolade A Awotedu, Nombulelo P Magula, Datshana P Naidoo, Albertino Damasceno, Alfred Chitsa Banda, Arthur Mutyaba, Basil Brown, Patrick Ntuli, Phindile Mntla, Lucas Ntyintyane, Rohan Ramjee, Pravin Manga, Bruce Kirenga, Charles Mondo, James B W Russell, Jacob M Tsitsi, Ferande Peters, Mohammed R Essop, Ayub Felix Barasa, Muhammad S Mijinyawa, Mahmoud U Sani, Taiwo Olunuga, Okechukwu Ogah, Adewole Adebiyi, Akinyemi Aje, Victor Ansa, Dike Ojji, Solomon Danbauchi, James Hakim, Jonathan Matenga, and Salim Yusuf.
• The Cardiac Clinic, Department of Medicine, Groote Schuur Hospital, Cape Town, South Africa. bongani.mayosi@uct.ac.za
• Am. Heart J. 2013 Feb 1;165(2):109-15.e3.

BackgroundIn spite of antituberculosis chemotherapy, tuberculous (TB) pericarditis causes death or disability in nearly half of those affected. Attenuation of the inflammatory response in TB pericarditis may improve outcome by reducing cardiac tamponade and pericardial constriction, but there is uncertainty as to whether adjunctive immunomodulation with corticosteroids and Mycobacterium w (M. w) can safely reduce mortality and morbidity.ObjectivesThe primary objective of the IMPI Trial is to assess the effectiveness and safety of prednisolone and M. w immunotherapy in reducing the composite outcome of death, constriction, or cardiac tamponade requiring pericardial drainage in 1,400 patients with TB pericardial effusion.DesignThe IMPI trial is a multicenter international randomized double-blind placebo-controlled 2 × 2 factorial study. Eligible patients are randomly assigned to receive oral prednisolone or placebo for 6 weeks and M. w injection or placebo for 3 months. Patients are followed up at weeks 2, 4, and 6 and months 3 and 6 during the intervention period and 6-monthly thereafter for up to 4 years. The primary outcome is the first occurrence of death, pericardial constriction, or cardiac tamponade requiring pericardiocentesis. The secondary outcome is safety of immunomodulatory treatment measured by effect on opportunistic infections (eg, herpes zoster) and malignancy (eg, Kaposi sarcoma) and impact on measures of immunosuppression and the incidence of immune reconstitution disease.ConclusionsIMPI is the largest trial yet conducted comparing adjunctive immunotherapy in pericarditis. Its results will define the role of adjunctive corticosteroids and M. w immunotherapy in patients with TB pericardial effusion.Copyright © 2013 Mosby, Inc. All rights reserved.

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