Reproduction and Survival After Cardiac Defect Repair

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005190
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: October 2001
  Purpose

To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women with corrected congenital heart disease and the risk of prematurity and occurrence of congenital heart defects in offspring.


Condition
Cardiovascular Diseases
Heart Diseases
Defect, Congenital Heart
Aortic Valve Stenosis
Transposition of Great Vessels
Ductus Arteriosus, Patent
Heart Septal Defects, Atrial
Heart Septal Defects, Ventricular
Down Syndrome
Tetralogy of Fallot
Pulmonic Stenosis
Coarctation of Aorta

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1986
Estimated Study Completion Date: December 1998
Detailed Description:

BACKGROUND:

Since 1960, surgical advances have led to correction of congenital heart defects in children who otherwise may not have achieved maturity. Consequently, it became increasingly important to understand the long-term morbidity, mortality and functional status of these patients. Because of the tremendous outlay of time, money and personnel devoted to prolonging the lives of children with congenital heart defects, it was vital to examine the accomplishment of long-term goals: achievement of a normal lifespan as a functioning, effective member of society.

DESIGN NARRATIVE:

Preoperative, operative, and postoperative data for each patient were entered into the registry data base at chart review. Follow-up for each patient was gathered by mail questionnaire, telephone survey, and the National Death Index. Questionnaires assessed morbidity, functional status, and reproduction. Pregnancy and major events were confirmed from physicians' records. Follow-up for tetralogy of Fallot, ventricular septal defect, and atrial septal defect was conducted in years 1, 3, and 5, and for transposition of the great arteries, aortic stenosis, pulmonic stenosis, patent ductus arteriosus, and coarctation of the aorta in years 2 and 4. Chart review was completed in year 2 and cases were then identified prospectively. Actuarial analysis and Cox proportional hazards models determined mortality, major morbidity, and their risk factors. Reproductive data were analyzed per years of fertility for the cohort, and compared to Oregon population statistics. During 1988-1989, chart review and data abstraction were completed for children having surgical corrections from 1958-1987 for the eight defects under study. Also, during 1988-1989, children undergoing cardiac surgery for the eight defects were added to the registry.

The study was renewed in 1993 to sustain and expand the registry of all Oregon children 18 years of age or younger undergoing surgical repair from 1958 to the present of 14 major congenital heart defects: tetralogy of Fallot (TOF), ventricular septal defect (VSD), atrial septal defect (ASD), coarctation of the aorta, pulmonic stenosis (PS), aortic stenosis (AS), transposition of the great arteries, patent ductus arteriosus (PDA), tricuspid atresia (TA), total anomalous pulmonary venous return (TAPVR), pulmonary atresia with intact ventricular septum (PA), PA with VSD, partial atrioventricular canal (AVC), and complete AVC. The first eight defects were included in the registry: TOF (n =438). VSD (n =402), ASD (n =496), COA (n =479), AS (n = 175), PS (n = 200), TGA (n = 169), and PDA (n = 533). All cases of surgical treatment of TA, TAPVR, PA, PA with VSD, and partial and complete AVC from 1958 to the present were added to the registry. Preoperative, operative, and postoperative data for each patient were entered into the database from chart review. Each hospital was visited twice yearly to ascertain new cases. Individuals were followed every two years for intercurrent events by mailed questionnaire or phone interview. Questionnaires and interviews assessed major morbidity, functional status, and reproduction. Pregnancy, major events, and recurrent CHD were confirmed by medical records. Actuarial analysis and the Cox proportional hazards model determined mortality, morbidity, and their risk factors, and compared observed survival with expected population survival. Reproductive data were analyzed per years of fertility for cohort, and compared to Oregon population statistics.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  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.

No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005190     History of Changes
Other Study ID Numbers: 1068
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Pulmonary Valve Stenosis
Constriction, Pathologic
Cardiovascular Diseases
Heart Diseases
Aortic Valve Stenosis
Down Syndrome
Heart Septal Defects
Congenital Abnormalities
Tetralogy of Fallot
Heart Septal Defects, Atrial
Heart Septal Defects, Ventricular
Ductus Arteriosus, Patent
Heart Defects, Congenital
Transposition of Great Vessels
Aortic Coarctation
Pathological Conditions, Anatomical
Heart Valve Diseases
Ventricular Outflow Obstruction
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Chromosome Disorders
Genetic Diseases, Inborn
Cardiovascular Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014