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

NCT00007358 | Completed

• 2 other identifiers: R01AR046265NIAMS-055
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Congenital Heart Block; Neonatal Lupus; Atrioventricular Nodal Dysfunction; Myocardial Injury

Keywords

Dexamethasone; Anti-SSA/Ro antibodies; Anti-SSB/La antibodies; Ultrasound; Atrioventricular (AV) nodal dysfunction; Echocardiograms; Mothers

Outcome Measures

Primary Outcomes (3)

• Neonatal ventricular heart rate

  Measured over 5 months

• Fractional shortening

  Measured over 5 months

• Abnormal fluid collection

  Measured over 5 months

Secondary Outcomes (5)

• Change in degree of heart block

  Measured over 5 months

• Gestational age (weeks) at birth

  Measured over 5 months

• Birth weight

  Measured over 5 months

• Cardiothoracic ratio

  Measured over 5 months

• EKG and echocardiogram

  Measured over 5 months

Study Arms (1)

1

EXPERIMENTAL

Depending on patient and physician decision, a steroid may be administered during pregnancy.

Drug: Dexamethasone or other corticosteroid

Interventions

Dexamethasone or other corticosteroid DRUG

Administered during the third trimester of pregnancy

1

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Mother must have anti-Ro and/or anti-La antibody
• Fetal bradyarrhythmia (slow, abnormal heart rhythm)

You may not qualify if:

• Fetal heart abnormalities that may cause newborn CHB and could account for atrioventricular (AV) block
• 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
• Mother is taking more than 10 mg of prednisone per day

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (4)

Yale University Medical Center

New Haven, Connecticut, 06520, United States

Location

St. Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Hospital for Joint Diseases

New York, New York, 10003, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

Related Publications (13)

• 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. doi: 10.1002/1529-0131(199911)42:113.0.CO;2-3.

  PMID: 10555029 BACKGROUND

• 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. doi: 10.1016/s0002-9149(00)00867-5. No abstract available.

  PMID: 10913494 BACKGROUND

• Buyon JP, Waltuck J, Kleinman C, Copel J. In utero identification and therapy of congenital heart block. Lupus. 1995 Apr;4(2):116-21. doi: 10.1177/096120339500400207.

  PMID: 7795614 BACKGROUND

• Copel JA, Buyon JP, Kleinman CS. Successful in utero therapy of fetal heart block. Am J Obstet Gynecol. 1995 Nov;173(5):1384-90. doi: 10.1016/0002-9378(95)90621-5.

  PMID: 7503173 BACKGROUND

• 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. doi: 10.1191/0961203302lu173oa.

  PMID: 11999879 BACKGROUND

• 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. doi: 10.1007/BF02722656.

  PMID: 12139139 BACKGROUND

• 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. doi: 10.1002/uog.11.

  PMID: 12528158 BACKGROUND

• Askanase A, Friedman D, Glickstein J, Kim M, Buyon J. Potential Therapeutic window from normal heart rate (NHR) to advanced heart blcok and early detection of firts degree block by echocardiographic measurement of the mechanical PR interval. Arthritis Rheum. 2002; 46(suppl);5321.

  BACKGROUND

• 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. doi: 10.1080/0891693031000067340.

  PMID: 12765470 BACKGROUND

• Buyon JP, Clancy RM. Neonatal lupus syndromes. Curr Opin Rheumatol. 2003 Sep;15(5):535-41. doi: 10.1097/00002281-200309000-00003.

  PMID: 12960477 BACKGROUND

• 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. doi: 10.1016/s0735-1097(98)00161-2.

  PMID: 9626848 BACKGROUND

• Friedman D, Duncanson Lj, Glickstein J, Buyon J. A review of congenital heart block. Images Paediatr Cardiol. 2003 Jul;5(3):36-48.

  PMID: 22368629 BACKGROUND

• Friedman DM, Kim MY, Copel JA, Davis C, Phoon CK, Glickstein JS, Buyon JP; PRIDE Investigators. Utility of cardiac monitoring in fetuses at risk for congenital heart block: the PR Interval and Dexamethasone Evaluation (PRIDE) prospective study. Circulation. 2008 Jan 29;117(4):485-93. doi: 10.1161/CIRCULATIONAHA.107.707661. Epub 2008 Jan 14.

  PMID: 18195175 RESULT

MeSH Terms

Conditions

Congenital heart block; Neonatal Systemic lupus erythematosus

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Jill P. Buyon

  Hospital for Joint Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2000
• First Posted: December 18, 2000
• Study Start: October 1, 2000
• Primary Completion: April 1, 2007
• Study Completion: October 1, 2008
• Last Updated: March 11, 2016

Record last verified: 2016-03

Locations

US (4)