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

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ClinicalTrials.gov Identifier: NCT01774890
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Amiram Nir, 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.


Condition or disease
Congenital Heart Disease

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Actual Study Start Date : March 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources




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

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

Biospecimen Retention:   Samples Without DNA
Blood


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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

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

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 Posted: January 24, 2013    Key Record Dates
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