Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus
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Purpose
Some newborns are born with congenital heart block (CHB), a condition occurring in babies with neonatal lupus. The first part of the study will test the effectiveness of fluorinated steroids, including dexamethasone, in improving the heart function and general health of newborns who have auto-antibody-associated CHB. The second part of this study will use ultrasound and heart monitoring to observe high-risk pregnant women and their fetuses during the third trimester of pregnancy.
| Condition | Intervention |
|---|---|
|
Congenital Heart Block Neonatal Lupus Atrioventricular Nodal Dysfunction Myocardial Injury |
Drug: Dexamethasone or other corticosteroid |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of Dexamethasone in Neonatal Lupus Congenital Heart Block; PRIDE (PR Interval and Dexamethasone Evaluation) in Congenital Heart Block |
- Neonatal ventricular heart rate [ Time Frame: Measured over 5 months ] [ Designated as safety issue: Yes ]
- Fractional shortening [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- Abnormal fluid collection [ Time Frame: Measured over 5 months ] [ Designated as safety issue: Yes ]
- Change in degree of heart block [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- Gestational age (weeks) at birth [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- Birth weight [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- Cardiothoracic ratio [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
- EKG and echocardiogram [ Time Frame: Measured over 5 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2000 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Depending on patient and physician decision, a steroid may be administered during pregnancy.
|
Drug: Dexamethasone or other corticosteroid
Administered during the third trimester of pregnancy
|
Detailed Description:
CHB is an abnormal condition in which the heart beats slowly. This is a disease that is strongly associated with maternal antibodies to SSA/Ro and SSB/La ribonucleoproteins. This study hopes to clarify the causes of CHB and develop appropriate treatments. The study has two parts.
The first part of the study will be prospective; it will determine if fluorinated steroids given to women prior to birth improves the heart function and well-being of their newborns. This part of the study will evaluate fetuses diagnosed in utero with CHB during the third trimester of pregnancy. Diagnosis of CHB must occur at least 6 weeks before the baby is born to allow for sufficient data collection. It will be the decision of the physician and the mother as to whether a steroid will be administered. Fetuses will be evaluated before delivery by electrocardiogram (ECG) to detect abnormal fluid collection and by ultrasound to monitor heartbeat. After birth, newborns will be assessed for overall pumping strength of the heart and for abnormal heartbeat. Blood will be drawn from the mother at the time of enrollment and during delivery. Visits will occur over a span of approximately 5 months.
The second part of this study will be observational; the purpose is to identify classic indicators of heartbeat dysfunction and heart injury in newborns with CHB. The goal of this part of the study is to better understand the stages of heart injury, the role of anti-Ro/La antibodies in CHB, and procedures that may reverse heart block. Mothers considered to be at high risk for having a child with CHB will undergo weekly ECGs from 16 weeks into their pregnancy until Week 24, then will have an ECG every other week from Week 24 through Week 34. There will be a total of 15 visits to conduct these ECGs. Blood will be drawn at the first ECG visit and during delivery. Visits will occur over a span of 4 months.
For both parts of the study, babies will undergo ECGs after delivery and at one year of age. Additional tests not related to the study may be ordered by the physician.
Eligibility| Ages Eligible for Study: | 16 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Prospective Part of Trial:
- Mother must have anti-Ro and/or anti-La antibody
- Fetal bradyarrhythmia (slow, abnormal heart rhythm)
Exclusion Criteria for Prospective Part of Trial:
- Fetal heart abnormalities that may cause newborn CHB and could account for atrioventricular (AV) block
Inclusion Criteria for Observational Part of Trial:
- Mother must have anti-Ro and/or anti-La antibody
- Fetus must have documented normal heartbeat prior to the 16th week of pregnancy
- Fetus must have a structurally normal heart
- Mother must be enrolled during the 16th, 17th, or 18th week of pregnancy
Exclusion Criteria for Observational Part of Trial:
- Mother is taking more than 10 mg of prednisone per day
Contacts and Locations| United States, Connecticut | |
| Yale University Medical Center | |
| New Haven, Connecticut, United States, 06520 | |
| United States, New Jersey | |
| St. Barnabas Medical Center | |
| Livingston, New Jersey, United States, 07039 | |
| United States, New York | |
| Hospital for Joint Diseases | |
| New York, New York, United States, 10003 | |
| New York University Medical Center | |
| New York, New York, United States, 10016 | |
| Principal Investigator: | Jill P. Buyon | Hospital for Joint Diseases |
More Information
Publications:
| Responsible Party: | Jill Buyon, New York University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00007358 History of Changes |
| Other Study ID Numbers: | R01 AR46265, R01AR046265, NIAMS-055 |
| Study First Received: | December 19, 2000 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by New York University School of Medicine:
|
Dexamethasone Anti-SSA/Ro antibodies Anti-SSB/La antibodies Ultrasound |
Atrioventricular (AV) nodal dysfunction Echocardiograms Mothers |
Additional relevant MeSH terms:
|
Heart Block Lupus Erythematosus, Systemic Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013