ST2, a Novel Biomarker for Cardiac Remodeling in Adults With Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT01774890
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The remarkable improvement in survival of children with congenital disease has led to a continuously growing number of adults with congenital heart disease in the developed world. Many of these patients had had cardiac surgery at early age, the may live for many years with pressure overload, volume overload, systolic or diastolic dysfunction, cyanosis or any combination of the above. These past and ongoing cardiac insults often result in significant cardiac remodeling. A biomarker for fibrosis and remodeling may have enormous clinical and prognostic value for these patients.

Serum biomarkers are now integrated in many fields in medicine. In cardiology, a number of biomarkers are used. In the last decade, our group has focused on the natriuretic peptides as markers for heart disease in infants and children. This resulted in many studies and more than 25 publications in the medical literature. We believe that the newly discovered cardiac marker, ST2, will emerge as an important addition to cardiac evaluation in the coming years.The aim of this study is to measure ST2 levels in patients with congenital right heart disease and correlate ST2 levels to clinical status, imaging and prognosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Study Start: 2013-03
• Primary Completion: 2015-01
• Study Completion: 2017-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Adults (age>18 y)
• congenital heart disease

Exclusion Criteria

• Additional lung diseases, renal disease or inflammatory disease.
• Patients who underwent therapeutic intervention between the MRI and the ST2 - measurements.
• Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NYHA classification and/or 6 minute walk distance	six months

Secondary Outcome Measures

Name	Time	Method
Hemoglobin level	six months

Trial Locations

Locations (1)

Hadassah Medical Organizrtion; 🇮🇱 Jerusalem, Israel