Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00007358
First received: December 19, 2000
Last updated: May 1, 2013
Last verified: May 2013
  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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007358

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
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Jill P. Buyon Hospital for Joint Diseases
  More Information

Publications:
Friedman DM, Duncanson LJ, Glickstein J, Buyon JP. A review of congenital heart block. Images in Paediatric Cardiology. 16:36-48, 2003.

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
Wounds and Injuries
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

ClinicalTrials.gov processed this record on July 28, 2014