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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Amiram Nir, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01774890
First received: January 22, 2013
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition
Congenital Heart Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • NYHA classification and/or 6 minute walk distance [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hemoglobin level [ Time Frame: six months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults born with congenital heart disease in stable clinical condition

Criteria

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
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774890

Locations
Israel
Hadassah Medical Organizrtion Recruiting
Jerusalem, Israel
Contact: Lamberg Hadas    972-2-6711111    hadasl@hadassah.org.il   
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Amiram Nir, Head, Adult Congenital Heart Disease Unit, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01774890     History of Changes
Other Study ID Numbers: 0599-12-HMO
Study First Received: January 22, 2013
Last Updated: September 10, 2013
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 19, 2014