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

NCT ID: NCT01774890

Last Updated: 2017-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Amiram Nir

Head, Adult Congenital Heart Disease Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hadassah Medical Organizrtion

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0599-12-HMO

Identifier Type: -

Identifier Source: org_study_id

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