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

March 10, 2016 updated by: NYU Langone Health

Study of Dexamethasone in Neonatal Lupus Congenital Heart Block; PRIDE (PR Interval and Dexamethasone Evaluation) in Congenital Heart Block

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University Medical Center
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • St. Barnabas Medical Center
    • New York
      • New York, New York, United States, 10016
        • New York University Medical Center
      • New York, New York, United States, 10003
        • Hospital for Joint Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 48 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal ventricular heart rate
Time Frame: Measured over 5 months
Measured over 5 months
Fractional shortening
Time Frame: Measured over 5 months
Measured over 5 months
Abnormal fluid collection
Time Frame: Measured over 5 months
Measured over 5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in degree of heart block
Time Frame: Measured over 5 months
Measured over 5 months
Gestational age (weeks) at birth
Time Frame: Measured over 5 months
Measured over 5 months
Birth weight
Time Frame: Measured over 5 months
Measured over 5 months
Cardiothoracic ratio
Time Frame: Measured over 5 months
Measured over 5 months
EKG and echocardiogram
Time Frame: Measured over 5 months
Measured over 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Jill P. Buyon, Hospital for Joint Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2000

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

December 19, 2000

First Submitted That Met QC Criteria

December 16, 2000

First Posted (Estimate)

December 18, 2000

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

March 10, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AR046265 (U.S. NIH Grant/Contract)
  • NIAMS-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Injury

Clinical Trials on Dexamethasone or other corticosteroid

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe