Preventive IVIG Therapy for Congenital Heart Block
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
Neonatal lupus (NL) is the name given to a group of conditions that can affect the babies of
mothers who have certain autoantibodies against components of the body's cells that are
called SSA/Ro and SSB/La. NL can appear as a temporary rash that usually goes away by the
time the baby is 6 months old, or very rarely an abnormal blood or liver condition that also
improves with time - or it can cause permanent and often life-threatening damage to the fetal
heart, known as congenital heart block (CHB). In women with anti-Ro/La antibodies who are
pregnant for the first time, only about 2% of the babies will develop CHB. But for a woman
who has already had a child with CHB or NL rash, the risk of CHB in her next pregnancy is
nearly 20%. Unfortunately, once complete (third degree) heart block has been unequivocally
identified in a fetus, it has never been reversed with any of the therapies that have been
tried to date. Our previous studies strongly indicate that scarring of the conduction system
(the heart's own natural "pacemaker"), a consequence of inflammation triggered by the
mother's antibodies, damages or even destroys the cells that allow the heart to beat at a
normal rhythm. Instead, the damaged heart beats extremely slowly, to an extent that is fatal
to nearly 20% of affected babies (with most deaths occurring as fetal demises). Nearly all
surviving children with CHB require permanent implantation of a pacemaker device. Because it
is so difficult to treat or repair the damaged heart, a high-priority strategy is to try to
prevent the inflammatory process before irreversible scarring can occur. The aim of this
clinical-based proposal is to determine whether treating the pregnant mother with intravenous
immune globulin (IVIG) will prevent the development of CHB.
Phase:
Early Phase 1
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health
Collaborators:
Alliance for Lupus Research Lupus Research Alliance