ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus

This study is currently recruiting participants.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), April 2007

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00007358
  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

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

ChemIDplus related topics:   Dexamethasone    Dexamethasone acetate    Dexamethasone Sodium Phosphate    Doxiproct plus    Corticosteroids   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Official Title:   Study of Dexamethasone in Neonatal Lupus Congenital Heart Block; PRIDE (PR Interval and Dexamethasone Evaluation) in Congenital Heart Block

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Neonatal ventricular heart rate
  • fractional shortening
  • abnormal fluid collection

Secondary Outcome Measures:
  • Change in degree of heart block
  • gestational age (weeks) at birth
  • birth weight
  • cardiothoracic ratio
  • EKG and Echocardiogram

Estimated Enrollment:   150
Study Start Date:   October 2000
Estimated Study Completion Date:   August 2006

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

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

Contacts
Contact: Claudine Davis     212-598-6513     prideinchb@yahoo.com    

Locations
United States, Connecticut
Yale University Medical Center     Recruiting
      New Haven, Connecticut, United States, 06520
      Contact: Joshua A. Copel, MD     203-785-2671     joshua.copel@yale.edu    
United States, New Jersey
St. Barnabas Medical Center     Not yet recruiting
      Livingston, New Jersey, United States, 07039
      Contact: Deborah Friedman, MD     973-322-5691     dfriedman@sbhcs.com    
      Principal Investigator: Deborah Friedman, MD            
United States, New York
Hospital for Joint Diseases     Recruiting
      New York, New York, United States, 10003
      Contact: Claudine Davis     212-598-6513     prideinchb@yahoo.com    
      Contact: Jill P. Buyon, MD     212-598-6522     jill.buyon@med.nyu.edu    
      Principal Investigator: Jill P. Buyon, MD            
New York University Medical Center     Recruiting
      New York, New York, United States, 10016
      Contact: Claudine Davis     212-598-6513     prideinchb@yahoo.com    
      Contact: Jill P. Buyon, MD     212-598-6522     jill.buyon@med.nyu.edu    
      Principal Investigator: Jill P. Buyon, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Jill P. Buyon     Hospital for Joint Diseases    
  More Information

Publications:
Saleeb S, Copel J, Friedman D, Buyon JP. Comparison of treatment with fluorinated glucocorticoids to the natural history of autoantibody-associated congenital heart block: retrospective review of the research registry for neonatal lupus. Arthritis Rheum. 1999 Nov;42(11):2335-45.
 
Glickstein JS, Buyon J, Friedman D. Pulsed Doppler echocardiographic assessment of the fetal PR interval. Am J Cardiol. 2000 Jul 15;86(2):236-9. No abstract available.
 
Buyon JP, Waltuck J, Kleinman C, Copel J. In utero identification and therapy of congenital heart block. Lupus. 1995 Apr;4(2):116-21.
 
Copel JA, Buyon JP, Kleinman CS. Successful in utero therapy of fetal heart block. Am J Obstet Gynecol. 1995 Nov;173(5):1384-90.
 
Askanase AD, Friedman DM, Copel J, Dische MR, Dubin A, Starc TJ, Katholi MC, Buyon JP. Spectrum and progression of conduction abnormalities in infants born to mothers with anti-SSA/Ro-SSB/La antibodies. Lupus. 2002;11(3):145-51.
 
Friedman DM, Rupel A, Glickstein J, Buyon JP. Congenital heart block in neonatal lupus: the pediatric cardiologist's perspective. Indian J Pediatr. 2002 Jun;69(6):517-22. Review.
 
Friedman D, Buyon J, Kim M, Glickstein JS. Fetal cardiac function assessed by Doppler myocardial performance index (Tei Index). Ultrasound Obstet Gynecol. 2003 Jan;21(1):33-6.
 
Buyon JP, Clancy RM. Neonatal lupus: review of proposed pathogenesis and clinical data from the US-based Research Registry for Neonatal Lupus. Autoimmunity. 2003 Feb;36(1):41-50. Review.
 
Buyon JP, Clancy RM. Neonatal lupus syndromes. Curr Opin Rheumatol. 2003 Sep; 15(5): 535-41. Review.
 
Buyon JP, Hiebert R, Copel J, Craft J, Friedman D, Katholi M, Lee LA, Provost TT, Reichlin M, Rider L, Rupel A, Saleeb S, Weston WL, Skovron ML. Autoimmune-associated congenital heart block: demographics, mortality, morbidity and recurrence rates obtained from a national neonatal lupus registry. J Am Coll Cardiol. 1998 Jun;31(7):1658-66.
 
Friedman DM, Duncanson LJ, Glickstein J, Buyon JP. A review of congenital heart block. Images in Paediatric Cardiology. 16:36-48, 2003.

Publications indexed to this study:

Study ID Numbers:   R01 AR46265, NIAMS-055
First Received:   December 19, 2000
Last Updated:   April 25, 2007
ClinicalTrials.gov Identifier:   NCT00007358
Health Authority:   United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Congenital heart block  
Neonatal lupus  
Dexamethasone  
Anti-SSA/Ro antibodies  
Anti-SSB/La antibodies  
Ultrasound
Atrioventricular (AV) nodal dysfunction
Myocardial injury
Echocardiograms
Mothers

Study placed in the following topic categories:
Dexamethasone
Antibodies
Neonatal Systemic lupus erythematosus
Heart Diseases
Heart Block
Dexamethasone acetate
Congenital heart block
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Glucocorticoids
Hormones
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2008




Links to all studies - primarily for crawlers