Preventive Approach to Congenital Heart Block With Hydroxychloroquine
Status:
Completed
Trial end date:
2020-07-16
Target enrollment:
Participant gender:
Summary
Women with antibodies to proteins called SSA/Ro and or SSB/La face a 2% chance of having a
child with a life threatening heart condition regardless of whether they have very active
lupus, are in remission, or have only vague symptoms. This heart problem is referred to as
congenital heart block (the most serious being third degree complete block) and represents
damage thought to be caused by these autoantibodies. The heart beats abnormally slowly and
almost all children require permanent pacemakers before the age of 20. Importantly, women who
have had one child with heart block have a ten-fold higher risk of having another child with
the same heart condition. Unfortunately, even close monitoring by special techniques during
pregnancy does not reverse complete heart block once it is observed. Thus, treatments aimed
at prevention are critical. This study will evaluate for the first time whether
hydroxychloroquine, a drug used by many patients with SLE, prevents the development of this
heart condition. Data from laboratory experiments suggests that this drug, which crosses the
placenta, may decrease the inflammation initiated by the passage of anti-Ro antibodies to the
fetus. The study uses a Simon's 2-Stage design, and plans to enroll 19 patients in Stage 1
and 35 patients in Stage 2 if Stage 1 is successful. Patients can already be on
hydroxychloroquine or will be started as soon as pregnancy is confirmed. The hope is that
fewer than 3 cases of heart block will occur in Stage 1, and fewer than 6 cases will occur
out of all 54 patients if Stage 2 is reached. The results of this study are expected to
become an integral part of the counseling of women with anti-Ro/La antibodies who are
considering pregnancy.
Phase:
Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health