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

NCT01774890 | Completed

• 1 other identifier: 0599-12-HMO
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• NYHA classification and/or 6 minute walk distance

  six months

Secondary Outcomes (1)

• Hemoglobin level

  six months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults born with congenital heart disease in stable clinical condition

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organizrtion

Jerusalem, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Adult Congenital Heart Disease Unit

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: March 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2017
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

IL (1)