Preventive IVIG Therapy for Congenital Heart Block

Completed · Early Phase 1

Conditions studied: Congenital Heart Block, Neonatal Lupus, Autoantibody-associated Heart Block

In brief

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.

Key facts

Study ID: NCT00460928
Run by: NYU Langone Health
People needed: 20
Starts: 2007-04-01
Expected to finish: 2009-06-01
Last updated by the study team: 2019-09-30

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Mother must currently have an intrauterine pregnancy of less than 12 weeks.
Mother must have antibodies to SSA/Ro and/or SSB/La (will be confirmed in the clinical immunology laboratory at the Principal Investigator's institution, the NYU-Hospital for Joint Diseases).
Mother can be asymptomatic or have any rheumatic disease (such as lupus, Sjogren syndrome or other).
Mother must have had a previous child with one of the following: (a) congenital heart block (any degree) documented by EKG if live birth and/or echocardiogram if fetal demise; (b) characteristic neonatal lupus rash confirmed by photograph revealing annular lesions (evaluated by the PI), dermatology note, and/or biopsy; (c) congenital heart block and rash.
Mother may be taking 20 mg prednisone per day or less.

You may not qualify if…

Mother does not have antibodies to either SSA/Ro or SSB/La.
Mother is taking greater than 20 mg prednisone per day.
Mother has any condition that would contraindicate the use of IVIG: (a) prior serious reaction to IVIG infusion; (b) known IgA deficiency; (c) intolerance of volume load, e.g., congestive heart failure; (d) nephrotic syndrome.
Identification in the fetus of any of the following structural lesions considered causal for congenital heart block: (a) atrioventricular septal defects; (b) single ventricle; (c) developmental tricuspid valve disease; (d) L-transposition of the great arteries; (e) heterotaxia.

Where it is running

Saint Barnabas Medical Center — Livingston, New Jersey, United States
New York University School of Medicine / NYU-Hospital for Joint Diseases — New York, New York, United States

Full record on ClinicalTrials.gov

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