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

Congenital Heart Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01774890
• Other study ID #: 0599-12-HMO
• Status: Completed
• Phase: N/A
• First received: January 22, 2013
• Last updated: August 9, 2017
• Start date: March 2013
• Est. completion date: January 2017

Study information

• Verified date: August 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2017
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Locations

Country	Name	City	State
Israel	Hadassah Medical Organizrtion	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NYHA classification and/or 6 minute walk distance		six months
Secondary	Hemoglobin level		six months