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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01774890
First Posted: January 24, 2013
Last Update Posted: August 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amiram Nir, Hadassah Medical Organization
  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 Amiram Nir, Hadassah Medical Organization:

Primary Outcome Measures:
  • NYHA classification and/or 6 minute walk distance [ Time Frame: six months ]

Secondary Outcome Measures:
  • Hemoglobin level [ Time Frame: six months ]

Biospecimen Retention:   Samples Without DNA
Blood

Enrollment: 35
Actual Study Start Date: March 2013
Study Completion Date: January 2017
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01774890


Locations
Israel
Hadassah Medical Organizrtion
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

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
First Submitted: January 22, 2013
First Posted: January 24, 2013
Last Update Posted: August 10, 2017
Last Verified: August 2017

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