Trial Outcomes & Findings for Preventive Approach to Congenital Heart Block With Hydroxychloroquine (NCT NCT01379573)
NCT ID: NCT01379573
Last Updated: 2021-02-25
Results Overview
Echocardiogram reveals 2nd or 3rd degree AV block
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)
Results posted on
2021-02-25
Participant Flow
Participant milestones
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
400 mg/day Hydroxychloroquine
Hydroxychloroquine: women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
400 mg/day Hydroxychloroquine
Hydroxychloroquine: women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Overall Study
Lost to Follow-up
|
1
|
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Overall Study
Screen Failure
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10
|
Baseline Characteristics
Preventive Approach to Congenital Heart Block With Hydroxychloroquine
Baseline characteristics by cohort
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Age, Continuous
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32.7 years
n=93 Participants
|
|
Sex: Female, Male
Female
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63 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
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Region of Enrollment
United States
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62 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=93 Participants
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PRIMARY outcome
Timeframe: After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)Echocardiogram reveals 2nd or 3rd degree AV block
Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Recurrence of Advanced Heart Block
|
5 Participants
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SECONDARY outcome
Timeframe: After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)EKG at birth must confirm 1st degree AV block. It is also possible that a fetus developing 1st degree block on study medication might have developed more advanced block in the absence of study medication.
Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Prolonged PR Interval (>150msec)
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0 Participants
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SECONDARY outcome
Timeframe: After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)a) shortening fraction \<28% = 2 SD below normal mean or qualitatively reduced systolic function; b) cardio-thoracic ratio \>0.33; c) hydropic changes; d) moderate/severe tricuspid regurgitation.
Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Any Sign of Myocardial Injury, Without Change in Cardiac Rate or Rhythm
|
0 Participants
|
SECONDARY outcome
Timeframe: After enrollment at 16-18 weeks gestation, then weekly until 26 weeks, biweekly to 34 weeks, at birth (approximately 9 months), and at one year follow up (approximately 21 months from enrollment)(see title)
Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Echocardiographic Densities Consistent With EFE Confirmed Postnatally
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0 Participants
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SECONDARY outcome
Timeframe: Up to 9 monthsAn autopsy with full evaluation of the heart will be encouraged but cannot be mandated. If AV block or evidence of a cardiomyopathy can be "proven," then these will provide the basis for final categorization. If not possible, the death will not be considered a recurrence rate but will be reported.
Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Fetal Death Not Related to Cardiac Dysfunction
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0 Participants
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SECONDARY outcome
Timeframe: Up to 15 months (at birth - 9 months, and 6 months thereafter)Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Cutaneous Neonatal Lupus
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4 Participants
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SECONDARY outcome
Timeframe: At birth (approximately 9 months)(gestational age \<37 weeks at birth)
Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Prematurity
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9 Participants
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SECONDARY outcome
Timeframe: At birth (approximately 9 months)Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Birth Weight <10% in the Context of Gestational Age
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1 Participants
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SECONDARY outcome
Timeframe: At birth (approximately 9 months)Outcome measures
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 Participants
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Abnormal Fluid Collection
|
0 Participants
|
Adverse Events
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregnant Women With Previous Child With Cardiac Neonatal Lupus
n=63 participants at risk
400 mg/day Hydroxychloroquine
Hydroxychloroquine: Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
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|---|---|
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Pregnancy, puerperium and perinatal conditions
Maternal rash
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3.2%
2/63 • Number of events 2 • From time of enrollment to six months after delivery.
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|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
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3.2%
2/63 • Number of events 2 • From time of enrollment to six months after delivery.
|
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Pregnancy, puerperium and perinatal conditions
Spontaneous miscarriage
|
1.6%
1/63 • Number of events 1 • From time of enrollment to six months after delivery.
|
|
Pregnancy, puerperium and perinatal conditions
Severe itching
|
1.6%
1/63 • Number of events 1 • From time of enrollment to six months after delivery.
|
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Pregnancy, puerperium and perinatal conditions
Fall
|
1.6%
1/63 • Number of events 1 • From time of enrollment to six months after delivery.
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Pregnancy, puerperium and perinatal conditions
Placental abruption
|
1.6%
1/63 • Number of events 1 • From time of enrollment to six months after delivery.
|
|
Pregnancy, puerperium and perinatal conditions
Placenta previa
|
1.6%
1/63 • Number of events 1 • From time of enrollment to six months after delivery.
|
|
Pregnancy, puerperium and perinatal conditions
Abnormal neonatal liver function test lab values
|
1.6%
1/63 • Number of events 1 • From time of enrollment to six months after delivery.
|
|
Pregnancy, puerperium and perinatal conditions
Right bundle branch block
|
1.6%
1/63 • Number of events 1 • From time of enrollment to six months after delivery.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place